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A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) (FIGHT-207)

A Study to Evaluate the Effectiveness and Safety of Pemigatinib in Previously-treated, Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

Amit Mahipal
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101072-P01-RST
19-008116
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Inclusion Criteria:
 

  • Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable. 
  • Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion. 
  • Documentation of an FGFR1-3 gene mutation or translocation. 
  • Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit. 
  • Eastern Cooperative Oncology Group performance status 0 to 2.
  • Baseline archival tumor specimen (if < 12 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis. 
  • Willingness to avoid pregnancy or fathering children.


Exclusion Criteria:
 

  • Prior receipt of a selective FGFR inhibitor in the past 6 months. 
  • Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib. 
  • Cannot be a candidate for potentially curative surgery. 
  • Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination. 
  • Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment.
  • Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases). 
  • Known additional malignancy that is progressing or requires active treatment. 
  • History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
  • Clinically significant or uncontrolled cardiac disease. 
  • Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed). 
  • Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed). 
  • Known HIV infection. 
  • Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment. 
  • Women who are pregnant or breastfeeding.
Drug, Administration of antineoplastic agent, Drug therapy
Brain tumor, Cancer, Tumors and masses
Cancer treatment, Carrier of chromosome translocation, Genetic mutation, Intracranial tumor, Malignant neoplastic disease, Medical Oncology, Nervous system, Pemigatinib, Secondary malignant neoplastic disease, Solid tumor configuration, Tumor surgically unresectable, pemigatinib
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MK-1026-001 A Phase 1/2 Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of MK-1026 in Selected Subjects with Relapsed or Refractory Hematologic Malignancies

A Study of MK-1026 in Patients with Selected Hematologic Malignancies

Sameer Parikh
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101099-P01-RST
19-010567
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Inclusion Criteria:

  • Signed written informed consent granted prior to initiation of any study-specific procedures. 
  • 18 years of age and older.
  • For the dose escalation cohorts, relapsed or refractory subjects with a diagnosis of B-cell NHL, CLL/SLL and WM who have received at least two prior systemic therapies . Subjects must have failed or are intolerant to standard therapies and cannot be a candidate for standard salvage regimens. Subjects with low grade lymphoma must be progressing and requiring treatment.. 
  • For the expansion cohorts, the following criteria must be met:
    • Cohort A: Relapsed/Refractory (R/R) CLL/SLL subjects with at least 2 prior systemic therapies and previously treated with a covalent BTKi who must have a documented BTK mutation on C481 residue;
    • Cohort B: R/R CLL/SLL subjects who have failed or were intolerant to a BTKi with documentation of the absence of BTK mutation on C481 residue. In this study, intolerance to standard therapy is defined as having experienced a grade 3 or higher adverse event that was caused by the standard therapy and resulted in treatment discontinuation;
    • Cohort C: Richter's transformation subjects who have failed at least one prior therapy;
    • Cohort D: Follicular Lymphoma (FL) subjects who have failed at least 2 prior systemic therapies and are histology grade 1, 2, or 3A;
    • Cohort E: Mantle Cell Lymphoma (MCL) subjects who have failed at least 2 prior systemic therapies;
    • Cohort F: Marginal Zone Lymphoma (MZL) subjects who have failed at least 2 prior systemic therapies;
    • Cohort G: High-grade B-cell lymphoma subjects who have failed at least 2 prior systemic therapies and have known MYC and BCL2 and/or BCL6 translocations;
    • Cohort H: Waldenström macroglobulinemia (WM) subjects who have failed at least 2 prior systemic therapies.
  • Disease status requirement: 
    • For CLL subjects, symptomatic disease that mandates treatment (Hallek et al. 2018); 
    • For B-cell NHL subjects, measurable disease by imaging scan;
    • For WM, serum immunoglobulin M (IgM) with a minimum IgM level of ≥ 2 times the upper limit of normal (ULN). 
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 
  • Good organ function:
    • Creatinine clearance of ≥ 60 mL/min as estimated by the Cockcroft-Gault equation or by 24-hour urine collection;
    • Total bilirubin ≤ 1.5 x institutional ULN (total bilirubin of ≤ 3 x institutional ULN in subjects with documented Gilbert's syndrome);
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × institutional ULN;
    • Platelet count ≥ 50,000/µL;
    • Absolute neutrophil count (ANC) ≥ 1000/µL;
    • Hemoglobin (Hgb) ≥ 8.0 g/dL, stable for ≥ 1 week.
  • For men and women of child-bearing potential, willing to use adequate contraception (e.g., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study.
  • Female subjects of child-bearing potential must have a negative serum pregnancy test within 14 days of the first day of drug dosing.
  • Ability to swallow oral medications without difficulty.


Exclusion Criteria:

  • Had immunotherapy, radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 5 half-lives or four weeks (whichever is shorter) prior to treatment initiation, or oral therapy within 5 half-lives or one week (whichever is shorter) prior to treatment initiation. 
  • Transformation of FL to a more aggressive subtype of lymphoma or grade 3b FL.
  • Subjects currently being treated with the following drugs:
    • CYP 2C9 substrates with a narrow therapeutic index (such as warfarin, phenytoin);
    • CYP 2C8 substrates with a narrow therapeutic index (such as paclitaxel);
    • CYP 2C19 substrates with a narrow therapeutic index (such as S-mephenytoin);
    • CYP 2D6 substrates with a narrow therapeutic index (such as thioridazine, pimozide);
    • P-gp substrates with a narrow therapeutic index (such as digoxin)
      • Note: A washout period of at least 5 times the half-life after the last dose of any of the above treatments is required for a subject to be eligible for study enrollment. 
  • Prior allogeneic bone marrow transplant. 
  • Active central nervous system (CNS) involvement. 
  • Pregnant or breast-feeding women. 
  • Has significant, ongoing co-morbid conditions which would preclude safe delivery of the study drug. 
  • Uncontrolled illness including but not limited to ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, cardiac infarction in the past six months, and psychiatric illness that would limit compliance with study requirements. 
  • QTc prolongation (defined as a QTc > 450 msecs) or other significant electrocardiogram (ECG) abnormalities including 2nd degree atrioventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min). If the screening ECG has a QTc > 450 msecs, the ECG can be submitted for a centralized, cardiologic evaluation. 
  • Active human immunodeficiency virus (HIV) infection, Hepatitis B, or Hepatitis C infection. 
  • Other medical or psychiatric illness or organ dysfunction which, in the opinion of the Investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agent.
  • History of prior cancer within < 1 year, except for basal cell or squamous cell carcinoma of the skin, cervical cancer in situ or other in situ carcinomas.
Drug
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GCAR-7213: GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM) (GBM AGILE)

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

Evanthia Galanis
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101139-P01-RST
19-008128
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Newly-Diagnosed

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained.
  • Karnofsky performance status ≥ 60%. performed within a 14-day window prior to randomization.
  • Availability of tumor tissue representative of GBM from definitive surgery or biopsy.

Recurrent

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT).
  • Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.
  • Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression.
  • Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization.
  • Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed.

Newly-Diagnosed


Exclusion Criteria:

  • Received any prior treatment for glioma including:
    • Prior prolifeprospan 20 with carmustine wafer;
    • Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent;
    • Prior radiation treatment for GBM or lower-grade glioma;
    • Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial.
  • Extensive leptomeningeal disease.
  • QTc > 450 msec if male and QTc > 470 msec if female.
  • History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

Recurrent


Exclusion Criteria:

  • Early disease progression prior to 3 months (12 weeks) from the completion of RT.
  • More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy).
  • Received any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent.
  • Any prior treatment with prolifeprospan 20 with carmustine wafer.
  • Any prior treatment with an intracerebral agent.
  • Receiving additional, concurrent, active therapy for GBM outside of the trial.
  • Extensive leptomeningeal disease.
  • QTc > 450 msec if male and QTc > 470 msec if female.
  • History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

Eligibility last updated 2/16/22. Questions regarding updates should be directed to the study team contact.

Drug, Radiation, Administration of antineoplastic agent, Biopsy of brain tissue tumor, Drug therapy, Excision of lesion of brain tissue
Brain tumor, Cancer, Glioblastoma, Glioblastoma multiforme, Glioma, Recurrent cancer
Biological therapy for cancer, Brain tumor surgery, Cancer treatment, Chemotherapy, Glioblastoma multiforme, Gliosarcoma, Medical Oncology, Nervous system, Recurrent malignant neoplastic disease
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Mayo Clinic — Rochester, MN

ION-682884-CS3 A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of AKCEA-TTR-LRx in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Morie Gertz
All
18 years to 82 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-101170-P01-RST
19-011570
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Inclusion Criteria:
1. Aged 18 to 82 years at the time of informed consent 2. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal or abstinent 3. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject''s non-pregnant female partner must be using a highly effective contraceptive method 4. Diagnosis of hereditary transthyretin-mediated polyneuropathy as defined by meeting all 3 of the following:
• Stage 1 or Stage 2 Familial Amyloid Polyneuropathy (FAP) or Coutinho Stage
• Documented genetic mutation in the TTR gene
• Symptoms and signs consistent with neuropathy associated with transthyretin amyloidosis, including NIS ≥ 10 and ≤ 130
Exclusion Criteria:
1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a subject unsuitable for inclusion, including but not limited to abnormal safety labs 2. Karnofsky performance status ≤ 50 3. Other causes of sensorimotor or autonomic neuropathy (e.g., autoimmune disease), including uncontrolled diabetes 4. Prior liver transplant or anticipated liver transplant within 1-yr of Screening 5. New York Heart Association (NYHA) functional classification of ≥ 3 6. Acute coronary syndrome within 6 months of screening or major surgery within 3 months of Screening 7. Other types of amyloidosis 8. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study 9. Current treatment with any approved drug for hereditary TTR amyloidosis such as Vyndaqel® / Vyndamax™ (tafamidis), Tegsedi™ (inotersen), Onpattro™ (patisiran), off-label use of diflunisal or doxycycline, and tauroursodeoxycholic acid (TUDCA). If previously treated with Vyndaqel® / Vyndamax™, diflunisal or doxycycline, and TUDCA, must have discontinued treatment for at least 2 weeks prior to Study Day 1 10. Previous treatment with Tegsedi™ (Inotersen) or Onpattro™ (patisiran), or other oligonucleotide or RNA therapeutic (including siRNA)
Drug therapy, Drug
Amyloidosis, Neuropathies, Polyneuropathy
Eplontersen [USAN], Hematopoietic system, Inotersen [USAN], Polyneuropathy in amyloidosis, Transthyretin related familial amyloid cardiomyopathy, inotersen
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KT-US-471-0119, A Phase 1/2 Open-label, Multicenter Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects with Relapsed or Refractory Large B-cell Lymphoma (ZUMA-19)

Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects with Relapsed or Refractory Large B-cell Lymphoma

Saad Kenderian
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101173-P01-RST
19-012798
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Inclusion Criteria:

  • Adult subjects with large B-cell lymphoma, including Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, Primary mediastinal large B-cell lymphoma (PMBCL), High-grade B-cell lymphoma (HGBL), and Diffuse large B-cell lymphoma (DLBCL) arising from Follicular lymphoma (FL).
  • Subjects must have relapsed disease after 2 or more lines of systemic therapy, OR chemorefractory disease defined as the following: No response to first-line therapy, including the following: PD as best response to first therapy, SD as best response after ≥ 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP), with SD duration no longer than 6 months from the last dose of therapy, Note: Subjects who are intolerant to first-line chemotherapy are excluded OR No response to ≥ 2 lines of therapy, including the following: PD as best response to most recent therapy, SD as best response after ≥ 2 cycles of last line of therapy.
  • Subjects must have received adequate prior therapy including at a minimum: Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and An anthracycline-containing chemotherapy regimen, Subjects with transformed FL must have chemorefractory disease after transformation to DLBCL.
  • At least 1 measurable lesion according to the International Working Group (IWG) Lugano Classification {Cheson 2014}. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
  • Magnetic resonance imaging of the brain showing no evidence of CNS lymphoma.
  • At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists).
  • Toxicities due to prior therapy must be stable and recovered to Grade ≤ 1 (except for clinically nonsignificant toxicities such as alopecia).
  • Age 18 or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Additional Inclusion Criteria may apply.


Exclusion Criteria:

  • History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) or FL unless disease free for at least 3 years.
  • History of Richter’s transformation of chronic lymphocytic leukemia.
  • Autologous stem cell transplant (SCT) within 6 weeks of planned axicabtagene ciloleucel infusion.
  • History of allogeneic stem cell transplantation.
  • Prior CD19 targeted therapy or prior CAR T cell therapy.
  • History of PAP.
  • History of severe, immediate hypersensitivity reaction attributed to aminoglycosides.
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor.
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg positive) or hepatitis C (anti-HCV positive) infection. A history of hepatitis B or hepatitis C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
  • Additional Exclusion Criteria may apply.
Biologic/Vaccine, Drug
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MS200647_0055: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC)

Amit Mahipal
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101188-P01-RST
19-012227
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Inclusion Criteria:

  • Are ≥ 18 (or ≥ 20 in Japan and Taiwan or age legally considered to be an adult) years of age at the time of signing the informed consent. In Japan, a participant aged < 20 years of age but ≥ 18 years of age may participate if written informed consent from his/her parent or guardian is provided in addition to the participant’s written informed consent.
  • Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC, including intrahepatic CCA, extrahepatic CCA, gallbladder cancer, and ampulla of Vater’s cancer. The histological origin of ampullary carcinomas (intestinal, pancreaticobiliary, or other) will be collected.
  • Naïve to chemotherapy, immunotherapy, and interventional radiological treatment (transarterial chemo-embolization, transarterial embolization, transarterial infusion) for locally advanced or metastatic BTC. Participants whose disease has recurred ≥ 6 months after completion of neoadjuvant or adjuvant treatments will be considered eligible.
  • Availability of tumor tissue (primary or metastatic) (fresh or archival biopsies) before the first administration of study intervention. Availability of tumor tissue is mandatory except for the safety run-in part. Brush cytology and cell blocks are not acceptable. Tumor tissue (fresh or archival) must be suitable for biomarker assessment as described in the Laboratory Manual.
  • At least 1 measurable lesion according to RECIST 1.1. Participants in the safety run-in part do not require a measurable lesion at baseline.
  • ECOG PS of 0 or 1 at study entry and at Week 1, Day 1 prior to dosing.
  • Life expectancy of ≥ 12 weeks, as judged by the Investigator.
  •  Adequate hematological function defined by white blood cell count ≥ 2.0 × 10^9 /L with absolute neutrophil count ≥ 1.5 × 10^9 /L, lymphocyte count ≥ 0.5 × 10^9 /L, platelet count ≥ 100 × 10^9 /L, and hemoglobin (Hgb) ≥ 9 g/dL (participants may have been transfused) at study entry and at Week 1 Day 1 prior to dosing.
    • Previously transfused participants are allowed in the study with a stable Hgb of ≥ 9 g/dL at the time of study entry.
  • Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × upper limit of normal (ULN), an aspartate aminotransferase level ≤ 3.0 × ULN, and an alanine aminotransferase level ≤ 3.0 × ULN. For participants with liver involvement, aspartate aminotransferase ≤ 5.0 × ULN and alanine aminotransferase ≤ 5.0 × ULN are acceptable.
  • Adequate renal function defined by an estimated creatinine clearance (CrCl) > 50 mL/min according to the Cockcroft-Gault formula or by measure of CrCl from 24-hour urine collection.
    • CrCl (mL/min) = (140-age) × weight (kg) / (72 × serum creatinine Cr[jaffe]);
    • If female, × 0.85 ;
    • If creatinine is measured by the enzymatic method, add 0.2 and use as Cr[jaffe] = 0.2 + Cr[enzyme].
  • Albumin ≥ 2.8 g/dL.
  • Adequate coagulation function defined as prothrombin time or international normalized ratio ≤ 1.5 × ULN unless the participant is receiving anticoagulant therapy.
  • Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals (e.g., entecavir, tenofovir, or lamivudine; adefovir or interferon is not allowed) at study entry and with planned monitoring and management including baseline HBV DNA quantity according to appropriate labeling guidance. Participants receiving active hepatitis C virus (HCV) therapy must be on a stable dose at study entry and with planned monitoring and management according to appropriate labeling guidance of approved antiviral.
  • Are male or female:
    • Male Participants Agree to the following during the intervention period and for at least 4 months after the last dose of study intervention (35 days corresponding to the time needed to eliminate any study interventions; e.g., 5 terminal half-lives plus 90 days for spermatogenic cycle):
      • Refrain from donating sperm PLUS, either:  Abstain from any activity that allows for exposure to ejaculate; OR
      • Use a male condom:  When having sexual intercourse with a woman of childbearing potential who is not currently pregnant, and advise her to use a highly effective contraceptive method with a failure rate of < 1% per year since a condom may break or leak;
      • When engaging in any activity that allows for exposure to ejaculate.
    • Female participants are not pregnant or breastfeeding and at least 1 of the following conditions applies: Not a woman of childbearing potential; OR
    • If a woman of childbearing potential, agree to use a highly effective contraceptive method (i.e., with a failure rate of < 1% per year), preferably with low user dependency for the following time periods: 
      Before the first dose of study intervention(s), if using hormonal contraception:
      • Has completed at least one 4-week cycle of an oral contraceptive pill and has either had or has begun her menses; OR
      • Has used a depot contraceptive or extended-cycle contraceptive for at least 28 days and has a documented negative pregnancy test using a highly sensitive assay;
      • During the intervention period;
      • After the study intervention period (i.e., after the last dose of study intervention is administered) for at least 65 days (time needed to eliminate any study interventions, eg, 5 terminal half-lives plus 30 days for a menstrual cycle), and as indicated in the respective label (Summary of Product Characteristics [SmPC]) for gemcitabine and cisplatin. Participants have to agree to the following:
        • Women of childbearing potential should refrain from donating eggs from the start of dosing until 2 months after discontinuing study intervention.
        • The Investigator evaluates the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
      • Have a negative serum or highly sensitive urine pregnancy test, as required by local regulations, within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
      • The Investigator reviews the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early, undetected pregnancy.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.


Exclusion Criteria:

  • Previous and/or intercurrent cancers. With the exception of: curatively-treated cancers with no recurrence in > 3 years or early cancers treated with curative intent, including but not limited to cervical carcinoma in situ, superficial, noninvasive bladder cancer, basal cell carcinoma, squamous cell carcinoma in situ, or endoscopically resected gastrointestinal cancers limited in mucosal layer.
  • Rapid clinical deterioration not related to malignancy which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or study procedures at study entry and at Week 1 Day 1 prior to dosing.
  • Participants with symptomatic central nervous system (CNS) metastases are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they are judged to have fully recovered from treatment.
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).
  • Significant acute or chronic infections including:
    • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (testing at Screening is not required). If an Investigator has a strong suspicion of HIV infection without known history for a participant in screening, but the participant refuses testing, discuss with Medical Monitor to assess eligibility.
      • Note: HIV testing is not mandated for study inclusion; however, if it is performed at any point in screening or while on study, a site must consent the participant for HIV testing as per local standard guidance.
      • Active tuberculosis (presence of clinical symptoms, physical or radiographic findings of active tuberculosis).
      • Uncontrolled biliary infection. Biliary tract obstruction should be released by stenting or percutaneous transhepatic biliary drainage (PTBD). Participants with biliary obstruction should have adequate biliary drainage with no evidence of ongoing infection without antibiotics treatment at the time of enrollment as well as on Cycle 1 Day 1.
      • Active bacterial, fungal, or viral infection (with the exception of hepatitis B and hepatitis C) requiring systemic therapy at study entry and at Week 1 prior to dosing.
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
    • Participants with type 1 diabetes, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible. 
    • Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg of prednisone or equivalent per day.
    • Administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intra-ocular, or inhalation) is acceptable.
  • History of, or concurrent, interstitial lung disease.
  • Known history of hypersensitivity reactions to bintrafusp alfa or its products or known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0), any history of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma.
  • Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification ≥ Class II), or serious cardiac arrhythmia.
  • Other severe, acute, or chronic medical conditions, including immune colitis, inflammatory bowel disease, immune pneumonitis, or psychiatric conditions, including recent (within the past year) or active suicidal ideation or behavior. Participants with history of bleeding diathesis or recent major bleeding events considered by the Investigator as high risk for study intervention are also excluded.
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization.
  • Participants who are candidates for liver transplantation and who can receive the transplantation within a medically acceptable period.
  • Concurrent treatment with nonpermitted drugs. Participants who have completed prior adjuvant therapy > 6 months prior to randomization are eligible.
  • Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints), including but not limited to anti-PD-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody, or anti-4-1BB antibody is not allowed, inclusive of localized administration of such agents.
  • Prior therapy with any antibody/drug targeting TGFβ/TGFβ receptor.
  • Radiation within 28 days other than focal palliative bone-directed radiotherapy.
  • Systemic therapy with immunosuppressive agents within 7 days before the start of study intervention; or use of any investigational drug within 28 days before the start of study intervention.
  • Live vaccine administration within 4 weeks of study intervention administration.
  • Unable to tolerate CT or magnetic resonance imaging (MRI) in the opinion of the Investigator and/or allergy to contrast material.

Other Exclusions:

  • Major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy and stenting/PTBD for the purpose of releasing biliary tract obstruction).
  • Pregnancy or breastfeeding.
  • Known alcohol or drug abuse.
  • Legal incapacity or limited legal capacity.
Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Ampullary cancer, Cancer, Cholangiocarcinoma, Gallbladder cancer
1,2-Diaminocyclohexaneplatinum II citrate, Bintrafusp alfa, Biological therapy for cancer, Cancer treatment, Chemotherapy, Digestive system, Gemcitabine [USAN:INN:BAN], Medical Oncology, Primary cholangiocarcinoma of intrahepatic biliary tract, Primary malignant neoplasm of ampulla of Vater, Primary malignant neoplasm of extrahepatic bile duct, Primary malignant neoplasm of gallbladder, Secondary malignant neoplasm of biliary tract, cisplatin, gemcitabine
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2015LS095: Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer

A Study to Evaluate Exemestane in Post-Menopausal Women with Non-Small Cell Lung Cancer (NSCLC)

Mina Hanna
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101198-P01-ALCL
19-008976
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Inclusion Criteria:

  • Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab).
    • NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis.
  • Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase.
  • Tumor block or a minimum of 5 unstained slides.
  • Failed at least 1 prior FDA approved treatment for advanced NSCLC. 
  • Measureable disease by RECIST version 1.1.
  • Post-menopausal defined as:
    • Age ≥ 55 years and 1 year or more of amenorrhea;
    •  Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL;
    • Surgical menopause with bilateral oophorectomy.
  • ECOG performance status 0, 1 or 2.
  • Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record. 
  • Adequate organ function within 14 days of study enrollment defined as: 
  • Hematology:
    • Absolute neutrophil count (ANC) ≥ 1500/mm³;
    • Platelets ≥ 100,000/mm³;
    • Hemoglobin ≥ 8 g/dL.
  • Biochemistry: 
    • Total Bilirubin within normal institutional limits.
    • AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
    • Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min.
  • Must have recovered to CTCAE v 4 Grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e., peripheral neuropathy) is permitted. 
  • A minimum time period must elapse between the end of a previous treatment and start of study therapy: 
    • 1 week from the completion of radiation therapy for brain metastases;
    • 4 weeks from the completion of chemotherapy or any experimental therapy;
    • 4 weeks from prior major surgery (such as open biopsy or significant traumatic injury).
  • Voluntary written consent before any research related procedures or therapy.


Exclusion Criteria:

  • Known active CNS disease.
  • If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery.
  • Patients should be neurologically stable and requiring ≤ 10mg oral prednisone equivalence of steroids per day.
  • Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity ≥ Grade 2.
  • Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity.
  • Inability or unwilling to swallow study drug.
  • Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome).
  • Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e., black cohosh).
  • Known hypersensitivity to exemestane or its excipients.
  • Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment.
  • Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval.
  • Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane.
Drug
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Mayo Clinic Health System — Albert Lea, MN

2015LS095: Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer

A Study to Evaluate Exemestane in Post-Menopausal Women with Non-Small Cell Lung Cancer (NSCLC)

Stephan Thome
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101198-P01-MAIJ
19-008976
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Inclusion Criteria:

  • Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab).
    • NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis.
  • Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase.
  • Tumor block or a minimum of 5 unstained slides.
  • Failed at least 1 prior FDA approved treatment for advanced NSCLC. 
  • Measureable disease by RECIST version 1.1.
  • Post-menopausal defined as:
    • Age ≥ 55 years and 1 year or more of amenorrhea;
    •  Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL;
    • Surgical menopause with bilateral oophorectomy.
  • ECOG performance status 0, 1 or 2.
  • Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record. 
  • Adequate organ function within 14 days of study enrollment defined as: 
  • Hematology:
    • Absolute neutrophil count (ANC) ≥ 1500/mm³;
    • Platelets ≥ 100,000/mm³;
    • Hemoglobin ≥ 8 g/dL.
  • Biochemistry: 
    • Total Bilirubin within normal institutional limits.
    • AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
    • Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min.
  • Must have recovered to CTCAE v 4 Grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e., peripheral neuropathy) is permitted. 
  • A minimum time period must elapse between the end of a previous treatment and start of study therapy: 
    • 1 week from the completion of radiation therapy for brain metastases;
    • 4 weeks from the completion of chemotherapy or any experimental therapy;
    • 4 weeks from prior major surgery (such as open biopsy or significant traumatic injury).
  • Voluntary written consent before any research related procedures or therapy.


Exclusion Criteria:

  • Known active CNS disease.
  • If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery.
  • Patients should be neurologically stable and requiring ≤ 10mg oral prednisone equivalence of steroids per day.
  • Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity ≥ Grade 2.
  • Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity.
  • Inability or unwilling to swallow study drug.
  • Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome).
  • Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e., black cohosh).
  • Known hypersensitivity to exemestane or its excipients.
  • Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment.
  • Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval.
  • Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane.
Drug
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Mayo Clinic Health System — Mankato, MN

ASTX727-06: An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)

A Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)

Aref Al-Kali
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101227-P01-RST
19-012633
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Inclusion Criteria:

  • Adult patients, 18 years or older.
  • Previous participation in an Astex-sponsored ASTX727 clinical trial (including, but not limited to studies ASTX727-01, ASTX727-02, and ASTX727-04) in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex. 
  • Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating investigator at the time of parent study completion (subjects must not be withdrawn from the parent study until eligibility for this study is confirmed). 
  • Subject is able to understand and comply with the study procedures and understands the risks involved in the study. 
  • Subject provides written informed consent before undergoing any study-specific procedure.
  • Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 2 highly effective contraceptive methods of birth control and must agree not to become pregnant for 6 months after completing treatment; men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures and must agree not to father a child while receiving ASTX727 and for at least 3 months after completing ASTX727 treatment.


Exclusion Criteria:

  • Any subject who, in the opinion of the investigator, may have other conditions, organ dysfunction, or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.
Drug
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Mayo Clinic — Rochester, MN

Accelerated Resolution Therapy for Cancer Related Trauma and Distress: A Pilot Study

A Study to Assess Accelerated Resolution Therapy for Cancer Related Trauma and Distress

Cindy Tofthagen
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-101254-P01-RST
19-006093
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Inclusion Criteria:

  • 18 years of age or older.
  • Able to read, write and understand English.
  • Undergoing chemotherapy, radiation therapy, CAR-T, or bone marrow transplant for a cancer diagnosis within the previous 3 years or have metastatic cancer.
  • A mean score of at least 1.1 on the Cancer and Treatment Distress (CTxD) or at least one item rated at a 3 (often true) or 4 (nearly all the time).
  • A minimum score of 3 on the PC-PTSD-5.
  • Denial of suicidal ideation or intent, with no evidence of psychotic behavior.
  • Participants must be willing and able to travel to Mayo Clinic outside of normally scheduled visits to participate in the study.


Exclusion Criteria:

  • Individuals under 18 years of age.
Other, Cancer emotional and psychosocial support and education, Chemotherapy, Immunotherapy for cancer, Mental health care, Radiation oncology AND/OR radiotherapy, Trauma therapy
Cancer
Anxiety about body function or health, Anxiety about treatment, Biological therapy for cancer, Bone marrow transplant, Bone marrow transplant present, Cancer treatment, Chemotherapy, Distress, Malignant neoplastic disease, Medical Oncology, Psychotherapy, Radiation therapy, Secondary malignant neoplastic disease, Victim of psychological trauma
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Mayo Clinic — Rochester, MN

Feasibility of Transanal Robot-assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System: A Pilot Study

A Study to Determine the Feasibility of Transanal Robot-assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex? System

Louis Wong Kee Song
All
22 years to 99 years old
Feasibility
This study is NOT accepting healthy volunteers
0000-101255-P01-RST
19-009663
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Inclusion Criteria:

  • Age > 22 years (minimum age approved for use).
  • Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classification.
  • Colorectal lesions situated between 5 and 15 cm from the dentate line.
  • Colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter.
  • Colorectal subepithelial lesions < 2 cm in size.
  • Absence of uncorrectable bleeding disorder or coagulopathy (platelet count > 50,000 and INR < 1.5).
  • Ability to give informed consent.


Exclusion Criteria:

  • Inability to receive general anesthesia.
  • Presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy).
  • Excavated (0-III) colorectal lesions according to Paris classification.
  • Suboptimal colon preparation.
  • Clinical discretion of the provider.

 

Device
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Mayo Clinic — Rochester, MN

A Prospective Pilot Study Evaluating the Feasibility of Daily, Long-Term Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy for Localized, High-Risk Prostate Cancer

A Study to Evaluate the Feasibility of Daily, Long-Term, Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy

Robert Karnes
Male
18 years and over
Early Phase 1
This study is NOT accepting healthy volunteers
0000-101266-P01-RST
19-006675
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Inclusion Criteria:

  • Biopsy-proven histological diagnosis of localized prostate cancer (pT2 or specimen confined pT3).
  • Having undergone radical prostatectomy (open or laparoscopic) with bilateral pelvic lymph node dissection.
  • Negative surgical margins on final specimen.
  • Men that decline adjuvant therapy.
  • Detectable serum PSA of 0.1 ng/mL or >.
  • 24 months or less since radical prostatectomy at time of study screening.


Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • Treated prior to surgery with any form of hormone, antiandrogen, or androgen deprivation therapy.
  • Treated prior to surgery with any form of chemotherapy or radiotherapy.
  • Medical conditions/history that precludes subjects from following a fasting regimen including, but not limited to:
    • Diabetes Mellitus.
  • On hormone therapy (Casodex, GnRH agonist/antagonist).

 

 

Behavioral, Active surveillance of prostate cancer, Dietary regime, Modification of schedule of oral intake, Pelvic lymphadenectomy, Radical prostatectomy
Cancer, Prostate cancer
Active surveillance for prostate cancer, Cancer treatment, Local recurrence of malignant tumor of prostate, Lymphadenectomy, Malignant tumor of prostate, Medical Oncology, PSA test, Prostatectomy, Reproductive system
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Mayo Clinic — Rochester, MN

A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue

An Extension Study MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue

Lance Mynderse
Male
45 years and over
Feasibility
This study is NOT accepting healthy volunteers
0000-101275-P01-RST
19-011495
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Inclusion Criteria:
-Patients must have documented histological or cytological evidence of tumor(s) of the prostate. -Patients must be ≥ 45 years of age -Patients or their legal representative must be able to read, understand and sign an informed consent -Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging -Prostate cancer is diagnosed by MR image guided biopsies -Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy. -A non MRI visible cancer detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible cancer is singularly located in the contralateral hemisphere of the prostate; is Gleason 6 cancer; and comprises no more than 6mm linear extent of cancer in a single core on standard biopsy. -If any standard biopsy cores are positive on the same hemisphere of the prostate gland, they must be confirmed as likely to form a contiguous lesion with the target lesion detected on MRI and therefore be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (e.g., Left/Right, Base, Mid Gland, Apex). -Prior mpMRI results dated within 120 days prior to ablation. -No metastatic disease as per NCCN guidelines (www.nccn.org)
•Bone scan indicated to r/o metastatic disease if clinical T1 and PSA > 20 or T2 and PSA > 10 -PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml -The patient has given written informed consent after the nature of the study and alternative treatment options have been explained.
Exclusion Criteria:
-Patients with known hypersensitivity to any of the components of the PEGylated AuroShell suspension (polyethylene glycol, gold). -Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in questions prior to the day of dosing with PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication) -Patients with evidence of an active bacterial infection or with a fever ≥ 38.5 ºC (101.3 ºF) within 3 days of the first scheduled day of dosing -Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. -The presence of 3 or more MR Visible lesions positive on biopsy. -The presence of extra capsular, seminal vesicle invasion or metastatic disease. -Patient is unable to tolerate MRI (foreign body; i.e. pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil, etc.…) -Patient with inability to follow up. -History of prior treatment for prostate cancer. -Acute urinary tract infection. -Lower urinary tract symptoms defined by International Prostate symptom score (IPSS) > 20 -Patients with renal insufficiency with an estimated glomerular filtration (EGF) <= 30 are excluded, as they will not be able to undergo gadolinium enhance MRI. -Patients with acute or chronic hepatic dysfunction as evidenced by clinically important (> grade 1) changes in AST, ALT, bilirubin, or albumin, or either ALP or GGT values. -Patients with uncontrolled coagulopathies who are at increased risk of bleeding, or with abnormal PT (INR) or PTT. -Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes. -Other medical or surgical conditions, especially involving the cardiac, respiratory, renal or hepatic organ systems that would either be unsafe for the patient, would limit study participation, or that would impede the determination of causality of any adverse events experienced during the conduct of this study.
Laser ablation of prostate, MRI guided high intensity focused ultrasound ablation of thalamus, Device
Cancer, Prostate cancer
Ablation, Cancer treatment, Malignant tumor of prostate, Medical Oncology, Prostate biopsy, Reproductive system
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Mayo Clinic — Rochester, MN

ACNS1723, A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355) (ACNS1723)

Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

Jonathan Schwartz
All
3 years to 21 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-101282-P01-RST
19-010786
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Inclusion Criteria:

  • All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated.
  • Laboratory values used to assess eligibility must be no older than 7 days at the start of therapy.
  • Laboratory tests need not be repeated if therapy starts within 7 days of obtaining labs to assess eligibility.
  • If a post-enrollment lab value is outside the limits of eligibility, or laboratory values are > 7 days old, then laboratory evaluations must be re-checked within 48 hours prior to initiating therapy. If the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.
  • A pre- and post-operative brain MRI with and without contrast, and a baseline spine MRI with contrast, must be obtained prior to enrollment. The requirement for post-operative MRI is waived for patients who undergo biopsy only.
  • Patients must be ≥ 3 years and ≤ 21 years of age at the time of enrollment.
  • Patients must have eligibility confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1:
    • Newly diagnosed high-grade glioma with BRAFV600-mutation;
    • Positive or negative results for H3 K27M by immunohistochemistry (IHC)
    • Histologically confirmed high-grade glioma (WHO Grade III or IV) including but not limited to: anaplastic astrocytoma (AA), anaplastic pleomorphic xanthoastrocytoma (aPXA), anaplastic gangliogliomas (aGG), glioblastoma (GB), and high-grade astrocytoma, NOS.
  • Patients must have had histologic verification of a high-grade glioma diagnosis. CSF cytology by lumbar puncture must be done if clinically indicated and determined to be safe prior to study enrollment. If cytology proves positive, the patient would be considered to have metastatic disease and would, therefore, be ineligible.
  • A pre- and post-operative brain MRI with and without contrast and a baseline spine MRI with contrast must be obtained prior to enrollment. The requirement for a post-operative MRI is waived for patients who undergo biopsy only. If the spine MRI is positive, the patient would be considered to have metastatic disease and would be ineligible.
  • Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age. See https://www.cogmembers.org/site/pages/default.aspx?page=Prot_reference_materials under Standard Sections for Protocols.
  • Adequate Bone Marrow Function defined as:
    • Peripheral absolute neutrophil count (ANC) ≥ 1000/µL;
    • Platelet count ≥ 100,000/µL (transfusion independent);
    • Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions).
  • Adequate Renal Function defined as:
    • Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m^2; or
    • A serum creatinine based on age/gender as follows:
    • 3 to < 6 years | Male 0.8 | Female 0.8;
    • 6 to < 10 years | Male 1.0 | Female 1.0;
    • 10 to < 13 years | Male 1.2 | Female 1.2;
    • 13 to < 16 years | Male 1.5 | Female 1.4;
    • ≥ 16 years | Male 1.7 | Female 1.4.
    • The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR32 utilizing child length and stature data published by the CDC.
    • Adequate Liver Function defined as:
      • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; and
      • SGPT (ALT) ≤ 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
  • Central Nervous System Function defined as:
    • Patients with a seizure disorder may be enrolled if their seizures are well controlled while on non-enzyme inducing anticonvulsants permitted on this study.
  • Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive surgery (Day 0). If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.


Exclusion Criteria:

  • Patients with intrinsic brainstem or primary spinal cord tumors will be excluded.
  • Patients with metastatic disease (defined as neuraxis dissemination either by imaging or by cytology) will be excluded.
  • Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant for the treatment of HGG other than surgical intervention and/or corticosteroids.
  • Previous treatment with dabrafenib or another RAF inhibitor, trametinib or another MEK inhibitor, or an ERK inhibitor.
  • Patients with a history of a malignancy with confirmed activating RAS mutation.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib, trametinib, and their excipients.
  • Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease, or uncontrolled infection), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
  • Presence of active gastrointestinal (GI) disease or other condition (e.g., small bowel or large bowel resection) that will interfere significantly with the absorption of drugs.
  • History of Hepatitis B Virus, or Hepatitis C Virus infection (patients with laboratory evidence of cleared Hepatitis B Virus and/or Hepatitis C Virus may be enrolled).
  • History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following:
    • Recent myocardial infarction (within the last 6 months);
    • Uncontrolled congestive heart failure;
    • Unstable angina (within last 6 months);
    • Clinically significant (symptomatic) or known, uncontrolled cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker) except sinus arrhythmia within the past 24 weeks prior to the first dose of study treatment;
    • Coronary angioplasty or stenting (within last 6 months);
    • Intra-cardiac defibrillators;
    • Abnormal cardiac valve morphology (≥ Grade 2) documented by echocardiogram.
  • Patients with a history or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR), or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension).
  • Patients with presence of interstitial lung disease or pneumonitis.
  • Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of the study and for 4 months following discontinuation of study therapy.
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
  • Sexually active patients of reproductive potential (male or female) are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 4 months following discontinuation of study therapy. Male patients (including those who have had a vasectomy) taking dabrafenib and trametinib combination therapy must use a condom during intercourse while on study and for 16 weeks after stopping treatment, and should not father a child during these periods. Women of childbearing potential should use. effective non-hormonal contraception during therapy and for 4 weeks following discontinuation of dabrafenib and at least 4 months following the last dose of trametinib in patients taking combination therapy.  Women should be advised that dabrafenib may decrease the efficacy of hormonal contraceptives and an alternate method of contraception, such as barrier methods, should be used.
  • All patients and/or their parents or legal guardians must sign a written informed consent.
  • All institutional, FDA, and NCI requirements for human studies must be met.

Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.

Drug, Radiation
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Respiratory Causes Impacting Pilot Performance

A Study Evaluating Respiratory Causes Impacting Pilot Performance

Bruce Johnson
All
18 years to 50 years old
This study is NOT accepting healthy volunteers
0000-121641-H01-RST
19-000025
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Inclusion Criteria:

  • Between the ages of 18-50 years old.
  • Are of moderate to high fitness level and participate in regular physical activity.
  • Must have a body mass index (BMI) less than 31 kg/m^2.
  • Must be able to provide clear informed written consent.


Exclusion Criteria:

  • History of chronic respiratory, cardiovascular, metabolic disease or neural/cognitive disorders.
  • Anemia (< 12 g/dl for males, < 11 g/dl for females).
  • Migraines.
  • Active smoker (smoke within the past 6 years), or have more than 5 pack-years of smoking history
  • Females who are pregnant or trying to become pregnant.

Task 1 Specific:

  • History of pneumothorax, functionally limiting barotraumas or any inability to equalize tympanic pressure (e.g., during diving, swimming or flying).
  • Current dental abscesses or jaw pain consistent with severe dental caries.
  • Prior allergies or serious side effects from vasoconstrictors such as Afrin™ (oxymetazoline hydrochloride) utilized for sinus decongestion.
  • Hyperbaric exposure within the last 24 hours (for chamber visits).
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Prevention of Urinary Stones With Hydration (PUSH)

A Study to Evaluate Effectiveness of Preventing Urinary Stones With Hydration

John Lieske
All
12 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-121649-H01-RST
19-000054
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Inclusion Criteria:

  • Aged ≥ 12 years.
  • At least 1 symptomatic stone event (passage or procedural intervention) within 3 years prior to enrollment or a symptomatic stone event within 5 years if the patient also has new stone formation detected on imaging during the last 5 years. Symptomatic stone defined as any of the following:
    • Stone passage;
    • Procedural intervention;
    • Radiographically or ultrasonographically confirmed stone with any of the following:
      • Gross hematuria;
      • Renal colic or atypical abdominal pain attributed to the stone, as determined by a treating provider;
      • A clinical pattern of intermittent symptoms consistent with intermittent obstruction at the ureteropelvic junction, as determined by a treating provider.
  • Low 24‐hr urine volume 1. ≥18 years old: <1.8 L/day 2. <18 years old: <20 ml/Kg/day up to 1.8L/day.
  • Able to provide informed consent (parental permission for children).
  • Owning and willing to use a smartphone or other device (e.g., tablet) compatible with the study‐provided wireless enabled "smart" bottle.


Exclusion Criteria:

  • Spinal cord injury.
  • Currently undergoing active treatment for cancer except basal cell skin cancer, or patients with a history of cancer who completed their initial therapy <1 year before screening. 
  • Known infectious (struvite), monogenic or other causes of stone disease for which therapies are likely to significantly alter course of stone disease:
    • Cystinuria;
    • Primary hyperoxaluria;
    • Primary xanthinuria;
    • Primary hyperparathyroidism;
    • Sarcoidosis;
    • Medullary sponge kidney.
  • History or presence of hyponatremia (serum sodium <130 mmol/L) or hypo‐osmolality (serum osmolality <275 mosm/kg).
  • Study participants with comorbidities that preclude high fluid intake or prior surgery precluding high fluid intake or leading to GI fluid losses:
    • History of or current Crohn's disease, ulcerative colitis, short gut syndrome (e.g. ileostomy, bowel bypass surgery to treat obesity, small bowel resection), chronic diarrhea, or GI tract ostomy.
    • History of malabsorptive (e.g., Roux‐en‐Y gastric bypass) or restrictive (e.g., sleeve gastrectomy) bariatric surgery procedures.
    • Congestive heart failure:
      • NYHA class II or greater; and/or
      • Hospital admission in the past year for heart failure.
    • Lung disease with a home oxygen requirement.
    • Chronic kidney disease (eGFR <30 ml/min/1.7 m2 over a 3‐month period):
      • For adults (age ≥18), we will use the CKD‐Epi equation which requires the measurement of serum creatinine only;
      • For children (age <18), we will use the bedside Schwartz (CKiD) formula.
    • Nephrotic syndrome (>3.5 grams of protein per 24 hours) g. Cirrhosis with ascites.
  • Women who are currently pregnant or planning pregnancy within 2 years.
  • Renal transplant recipient.
  • Bedridden study participants (ECOG ≥ 3).
  • Uncorrected anatomical obstruction of the urinary tract.
  • History of recurrent urinary tract infections (> 3 UTI/year proven by urine culture).
  • Exclusions due to medication use:
    • Chronic use of lithium'
    • Long‐term glucocorticoid use (> 7.5 mg prednisone daily for > 30 days prior to enrollment)'
    • Intake of narcotic medication on a daily basis for >30 days prior to enrollment'
    • Supplemental Vitamin C (> 1 g daily).
  • Individuals with stones that have developed after the initiation of medications that are strongly associated with USD such as carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide), high dose vitamin C (> 1 g daily), high dose calcium supplementation (> 1,200 mg daily) AND who have discontinued or plan to discontinue these medications.
  • Individuals with stones composed of medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir) AND who have discontinued or plan to discontinue these medications.
    • Note: Individuals who are on long‐term medications that increase the risk of stone disease, who cannot stop these medications due to other chronic conditions (e.g., HIV) and who may reduce their risk for stone recurrence through increased fluid intake, will be eligible to participate in the trial. Examples of these medications include:
      • Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide);
      • Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir).
  • Study participants <2 yrs life expectancy.
  • Non‐English Speakers.
  • History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).
  • Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney.
  • Psychiatric conditions impairing compliance with the study.
  • Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact the study participant's ability to participate in the protocol).
  • Individual who will be unable to participate in the protocol in the judgment of the investigator.
Behavioral, Education about prevention of recurrence of urinary tract calculi, Increased fluid diet
Bladder stones, Kidney stone
H/O: urinary stone, Kidney stone, Urinary system, Urolithiasis
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Researching Epilepsy in Adolescent Clinical Transitions

A Study to Research Epilepsy in Adolescent Clinical Transitions

Michael Zaccariello
All
14 years to 19 years old
This study is NOT accepting healthy volunteers
0000-121683-H01-RST
19-000343
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Inclusion Criteria:

  • Adolescents between the ages of 14 and 19 years of age.
  • Existing or newly diagnosed epilepsy.
  • Currently receiving continued care within the Mayo Clinic Pediatric Neurology Department.
  • Participants must live within approximately 70 miles of the Mayo Clinic Rochester campus.


Exclusion Criteria:
 

  • Adolescents with a history of severe intellectual disability based on chart review and/or prior neuropsychological testing (e.g., nonverbal, non-ambulatory).
Epilepsy
Aging out of youth care system, Epilepsy, Nervous system
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LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye. (LUMINA)

A Study Assessing the Effectiveness and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Wendy Smith
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-121711-P01-RST
19-000598
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Inclusion Criteria:

  • Non-Infectious Active Uveitis of the posterior segment of the eye.


Exclusion Criteria:

  • Females who are pregnant, nursing, or planning a pregnancy.
  • Confirmed or suspected infectious uveitis.
Drug, Other, Drug therapy, Injection of drug into vitreous, Sirolimus therapy
Uveitis
Posterior uveitis, sirolimus
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A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure (snOH)

A Study to Evaluate TD-9855 to Treat Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects with Primary Autonomic Failure

Phillip Low
All
30 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-121754-P01-RST
19-001003
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Inclusion Criteria:

  • Subject is male or female.
  • Subject is at least 30 years old.
  • Subject is female and must be nonpregnant and nonlactating. A woman of childbearing potential must have a documented negative pregnancy test at screening.
    • NOTE: A woman is considered to be of childbearing potential unless she is postmenopausal (amenorrheic for at least 2 years) or documented to be surgically sterile (bilateral tubal ligation or total hysterectomy). A female subject may be admitted to the study on the basis of a negative urine pregnancy test. If the urine bHCG (beta human chorionic gonadotropin) test is positive, a serum bHCG test must be performed. The pregnancy test must be confirmed negative for a subject to be eligible for this study.
  • During the study and for 30 days after receiving the last dose of the study drug, females of childbearing potential or males capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly) or agree to abstain from sexual intercourse.
  • Subject must meet the diagnostic criteria of nOH, as demonstrated by a sustained reduction in BP of ≥ 20 mmHg (systolic) or ≥ 10 mmHg (diastolic) within 3 min of being tilted up to ≥ 60° from a supine position as determined by a tilt-table test.
  • Subject must score at least a 4 on the Orthostatic Hypotension Symptom Assessment Question #1 at randomization visit.
  • For subjects with PD only: Subject has a diagnosis of PD according to the United Kingdom Parkinson’s Disease Society (UKPDS) Brain Bank Criteria (1992).
  • For subjects with MSA only: Subject has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008).
  • For subjects with PAF only: Subject has documented impaired autonomic reflexes, including the Valsalva maneuver performed within 24 months from the date of randomization.
  • Subject has plasma NE levels >100 pg/mL after being in seated position for 30 minutes.
  • Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures.
  • Subject is able to communicate well with the investigator and clinic staff, understands the expectations of the study and is able to comply with the study procedures, requirements, and restrictions.


Exclusion Criteria:
 

  • Subject has a known systemic illness known to produce autonomic neuropathy, including but not limited to amyloidosis and autoimmune neuropathies. Subject has diabetes mellitus and diagnosis of PAF. Subject with diabetes mellitus and either MSA or PD, will be evaluated on a case by case basis by the medical monitor and considered ineligible unless they meet all of the following criteria:
    • Well controlled type-2 DM in treatment with only oral medications and diet;
    • HgbA1C of ≤ 7.5% performed during screening or up to 12 weeks before screening;
    • No clinically evident peripheral neuropathy (e.g., normal sensory examination on peripheral extremities);
    • No known retinopathy (e.g., annual ophthalmic exam is sufficient);
    • No nephropathy (e.g., absence of albuminuria and GFR > 60).
  • Subject has a known intolerance to other NRIs or SNRIs.
  • Subject currently uses concomitant antihypertensive medication for the treatment of essential hypertension.
  • Subject has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half-lives, whichever is longer, prior to randomization or requires concomitant use until the follow-up visit.
  • Subject has changed dose, frequency, or type of prescribed medication for orthostatic hypotension within 7 days prior to randomization visit.
    •  Midodrine and droxidopa (if applicable) must be tapered off at least 7 days prior to randomization.
  • Subject has a known or suspected alcohol or substance abuse within the past 12 months (DSM-IV-TR® definition of alcohol or substance abuse).
  • Subject has a clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months.
  • Subject has used any monoamine oxidase inhibitor (MAO-I) within 14 days prior to randomization.
  • Subject has a history of untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the subject.
  • Subject has any significant uncontrolled cardiac arrhythmia.
  • Subject has a Montreal Cognitive Assessment (MoCA) ≤ 23.
  • Subject is unable or unwilling to complete all protocol specified procedures including questionnaires.
  • Subject had a myocardial infarction in the past 6 months or has current unstable angina. 
  • Subject has known congestive heart failure (New York Heart Association [NYHA] Class 3 or 4).
  • Subject has any malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma within the past 2 years prior to screening.
  • Subject has a known gastrointestinal (GI) condition, which in the investigator’s judgment, may affect the absorption of study medication (e.g., ulcerative colitis, gastric bypass).
  • Subject has psychiatric, neurological, or behavioral disorders that may interfere with the ability of the subject to give informed consent or interfere with the conduct of the study.
  • Subject is currently receiving any investigational drug or has received an investigational drug within 30 days of dosing. An investigational drug is defined as nonregulatory agency approved drug (e.g., Food and Drug Administration).
  • Subject has a clinically significant abnormal laboratory findings (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3.0 x upper limit of normal [ULN]; blood bilirubin [total] > 1.5 x ULN; estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2, or any abnormal laboratory value that could interfere with safety of the subject).
  • Subject has demonstrated a history of lifetime suicidal ideation and/or suicidal behavior, as outlined by the C-SSRS (Baseline/Screening Version) subject should be assessed by the rater for risk of suicide and the subject’s appropriateness for inclusion in the study.
  • Subject has a concurrent disease or condition that, in the opinion of the investigator, would confound or interfere with study participation or evaluation of safety, tolerability, or pharmacokinetics of the study drug.
  • Subject has known hypersensitivity to TD-9855 (ampreloxetine hydrochloride), or any excipients in the formulation.
  • Subject has:
    • confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) documented with coronavirus disease 2019 [COVID-19] positive test result, OR (ii) is suspected of SARS-CoV-2 infection (clinical features without documented test results two weeks after resolution of symptoms and remains asymptomatic until Day 1); OR
    • has been in close contact with a person with known (or suspected) SARS-CoV-2 infection and remains asymptomatic until Day 1.
Drug, Drug therapy, Tilt table test
Multiple system atrophy, Orthostatic hypotension, Parkinson's disease, Pure autonomic failure
Autonomic nervous system, Cardiovascular system, Multiple system atrophy, Parkinson's variant, Multiple system atrophy, cerebellar variant, Nervous system, Orthostatic hypotension, Parkinson's disease, Pure autonomic failure, Tilt table test
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A Phase 2/3, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Response Comparison of the Efficacy and Safety of a Topical Rapamycin Cream for the Treatment of Facial Angiofibromas (FA) Associated With Tuberous Sclerosis Complex (TSC) in Patients 6 Years of Age and Over

A Dose-Ranging Study to Evaluate the Effectiveness and Safety of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex

Megha Tollefson
All
6 years to 65 years old
Phase 2/3
This study is NOT accepting healthy volunteers
0000-121772-P01-RST
19-001189
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Inclusion Criteria:

  • Male and female patients aged ≥ 6 years and ≤ 65 years on the day informed consent is obtained.
  • Patients diagnosed with TSC based on the clinical diagnostic criteria of International Tuberous Sclerosis Complex Consensus Conference 2012 and presenting visible facial angiofibroma.
  • An FA severity score of 2 or 3 on the IGA scale.
  • Patients or their legal representatives capable of understanding the explanation of the clinical trial and who give written informed consent for participation.
  • Patients or their legal representatives able to maintain patient diaries following the instructions of the investigator or sub-investigator.


Exclusion Criteria:

  • Patients who cannot carry out the treatment plan or follow-up assessment.
  • Patients with serious skin lesions such as erosions or ulcers.
  • Patients with known hypersensitivity to any component of the study product.
  • Patients who have received rapamycin/sirolimus, everolimus, or temsirolimus within 3 months of enrolment.
  • Patients who received laser therapy or surgical therapy within 6 months prior to trial enrolment.
  • Patients who participated in any other clinical trial within 3 months prior to the day of enrolment.
  • Patients judged unsuitable for this clinical trial by the investigator or sub-investigator.
  • Pregnant or lactating females.
  • Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception.
  • Patients with immune dysfunction or receiving any form of immunosuppression.
  • Patients with severe FA, with a score of 4 on the IGA scale.
  • Patients with an FA severity score of less than 2 on the IGA scale.
Drug, Administration of drug or medicament to skin via topical route, Drug therapy
Tuberous sclerosis
Fibrous skin tumor of tuberous sclerosis, Tuberous sclerosis syndrome, sirolimus
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A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy

A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)

Fernando Fervenza
All
18 years to 65 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-121798-P01-RST
19-001395
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Inclusion Criteria:
 

  • Patients 18
    •65 years of age.
  • Diagnosed with primary IgAN.
  • Currently being treated for IgAN with stable, optimal therapy, including an ACE inhibitor or an ARB or a direct renin-inhibitor.
  • Has urine protein greater than or equal to 1 gram/24-hour. 
  • Has hematuria (blood cells present in urine).


Exclusion Criteria:
 

  • Patients less than 18 years or older than 65 years old.
  • Has renal disease other than IgAN.
  • Has a diagnosis of rapidly progressive glomerulonephritis. 
  • Has a diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis).
  • Has poor kidney function with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2. 
  • Has known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection or hepatitis B virus (HBV) infection.
  • Has on-going high blood pressure.
  • Treated with systemic corticosteroids or any immunosuppressant agents in the past 12 months .
  • Received an organ transplant.
Drug, Drug therapy
IgA nephropathy
Blood in urine, Primary IgA nephropathy, Proteinuria, Urinary system
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Adapting a Measure of Heart Failure to an Adolescent Population

A Study to Adapt a Measure of Heart Failure to an Adolescent Population

Jonathan Johnson
All
12 years to 21 years old
This study is NOT accepting healthy volunteers
0000-121800-H01-RST
19-001425
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Patient

Inclusion Criteria:

  • Adolescents and young adults age 12 to 21 years at time of consent who have had NYHA Class II or higher heart failure in the preceding two years.
  • Actively being followed by a pediatric heart failure specialist with at least one visit in the past year, or actively being followed by a pediatric cardiologist with Heart Failure as an active diagnosis and history of consultation with a pediatric heart failure specialist.
  • English speaking.
  • Inpatient or outpatient.
  • Any etiology of heart failure including but not limited to cardiomyopathy, myocarditis, and congenital heart disease, unless mentioned in Exclusion Criteria.
  • May have systolic or diastolic heart failure, or Fontan/single ventricle heart failure.
  • May have had advanced cardiac therapies including pacemakers, ICDs, ventricular assist devices, or cardiac transplant as long as other Inclusion Criteria are met.

Caregiver

Inclusion Criteria:

  • Parent(s)/guardian(s)/caregiver(s) of participating adolescent/young adult subjects with heart failure.
  • Age 18 or older.
  • English speaking.
  • Significant co-morbidities that may greatly impact their ability to distinguish symptoms of heart failure, such as: muscular dystrophy, active malignancy, or primary non-cardiac organ failure (e.g., renal failure with uremic cardiomyopathy).
  • Clinical condition that would interfere with their ability to participate in a focus group or interview (e.g., severe developmental delay or other cognitive impairment).

Patient


Exclusion Criteria:
 

  • Significant co-morbidities that may greatly impact their ability to distinguish symptoms of heart failure, such as: muscular dystrophy, active malignancy, or primary non-cardiac organ failure (e.g., renal failure with uremic cardiomyopathy).
  • Clinical condition that would interfere with their ability to participate in a focus group or interview (e.g., severe developmental delay or other cognitive impairment).

Caregiver


Exclusion Criteria:

  • Clinical condition that would interfere with their ability to participate in a focus group or interview (e.g., severe developmental delay or other cognitive impairment).

     

 

 

Heart failure
Cardiovascular system, Heart failure
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Clinical Performance of the Aptima? CMV Quant Assay on the Panther? System

A Study to Evaluate Clinical Performance of the Aptima? CMV Quant Assay on the Panther? System

Raymund Razonable
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121826-P01-RST
19-001676
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Inclusion Criteria:

  • Subject and/or legally authorized representative is willing and able to provide consent prior to study participation.
  • Subject is ≥ 18 years of age.
  • Subject is undergoing or a candidate for routine SOC monitoring per the collection sites’ CMV management protocol.
  • Subject meets one of the following two criteria:
    • Subject is a kidney, liver, lung, or heart transplant recipient; or
    • Subject is an allogeneic or autologous HSCTR.
  • Subject is serotype D+/R-, D-/R+ or D+/R+.
  • Subject has a positive CMV result of equal to or above the LLOQ (≥LLOQ) within 10 days prior to enrollment with no intervening negative CMV result below the LLOQ (<LLOQ) and/or TND by SOC viral load testing.


Exclusion Criteria:

  • Subject already participated in this study.
  • Subject is unsuitable for study participation based on the PI’s decision (e.g., unlikely to comply with study procedure(s), significant medical complication).
  • Subject is participating in another investigational study that the PI believes might interfere with the subject’s participation in this study.
CMV infection, Transplant-associated infection
Allogeneic stem cell transplant, Autologous stem cell transplant, Bone marrow transplant, Heart transplant, Kidney transplant, Liver transplant, Lung transplant
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Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation (OPTION)

A Study to Compare Anticoagulation with Left Atrial Appendage Closure after AF Ablation

Douglas Packer
All
18 years and over
Not Applicable, Feasibility
This study is NOT accepting healthy volunteers
0000-121835-P01-RST
19-001742
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Inclusion Criteria:

  • The subject is of legal age to participate in the study per the laws of their respective geography. 
  • Underwent a prior catheter ablation procedure for non-valvular AF between 90 and 180 days prior to randomization (sequential) or is planning to have clinically indicated catheter ablation within 10 days of randomization (concomitant). 
  • The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females. 
  • The subject is deemed to be suitable for the defined protocol pharmacologic regimen. 
  • The subject is able to undergo TEE examinations. 
  • The subject or legal representative is able to understand and is willing to provide written informed consent to participate in the trial. 
  • The subject is able and willing to return for required follow-up visits and examinations.


Exclusion Criteria:
 

  • The subject is currently enrolled in another investigational study that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed. 
  • The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoagulable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue OAC due to other medical conditions requiring chronic OAC therapy). 
  • The subject is deemed by the treating physician to be unsuitable for chronic anticoagulation and/or aspirin therapy due to bleeding risk, allergy, or other reasons. 
  • The subject had or is planning to have any cardiac or major non-cardiac interventional or surgical procedure (excluding non-valvular AF ablation and cardioversion) within 30 days prior to or 60 days after randomization [including, but not limited to: percutaneous coronary intervention (PCI), other cardiac ablation (VT ablation, etc.), etc.]. 
  • The subject had a stroke or transient ischemic attack (TIA) within the 60 days prior to randomization. 
  • The subject had a prior major bleeding event per ISTH definition within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event. 
  • The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to randomization.
  • The subject has a history of atrial septal repair or has an ASD/PFO device. 
  • The subject has an implanted mechanical valve prosthesis in any position. 
  • The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).
  • The subject has a documented life expectancy of less than two years.
  • The subject has a cardiac tumor. 
  • The subject has signs/symptoms of acute or chronic pericarditis. 
  • There is evidence of tamponade physiology. 
  • Contraindications (anatomical or medical) to percutaneous catheterization procedures. 
  • The subject has documented NYHA Class IV heart failure. 
  • The subject has documented surgical closure of the left atrial appendage. 
  • The subject has an active infection.
Device, Drug, Anticoagulant prophylaxis, Catheter ablation of arrhythmogenic focus, Left atrial appendage closure
Atrial fibrillation, Heart arrhythmias
Ablation, Atrial fibrillation, Atrial fibrillation ablation, Cardiovascular system, Percutaneous ablation
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A Prospective, Single-blind Study to Evaluate Software that Enables Image Segmentation, Registration, and Ablation Device Dosage Quantification for High-precision 3D Ablation of Liver Tumors

A Study to Evaluate Software On Cross-sectional Imaging Evaluation of Microwave-ablated Liver Tumors

Anil Kurup
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121863-H01-RST
19-002001
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Inclusion Criteria:

  • Patients that are undergoing liver tumor treatment with microwave ablation therapy.


Exclusion Criteria:
 

  • Pregnant women.
  • The liver tumor cannot be easily identified on a contrast-enhanced CT scan.
  • There are contraindications to the use of contrast required in the study.
  • Treatment of 4 or more liver tumors.

 

 

Cancer, Kidney cancer, Kidney tumor, Liver cancer, Liver tumor, Prostate cancer
Ablation, Cancer treatment, Digestive system, Kidney tumor ablation, Liver tumor ablation, Medical Oncology, Neoplasm of kidney, Neoplasm of liver, Neoplasm of prostate, Percutaneous ablation, Prostate tumor ablation, Reproductive system, Urinary system
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A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

A Study to Evaluate Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/ Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

William Hogan
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-121902-P01-RST
19-002346
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Inclusion Criteria:

  • Age 18 years or older at the time of enrollment on Segment A.
  • Patients with acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 5% blasts in the bone marrow.
  • Patients with myelodysplasia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with <5% vs. 5-10% blasts in this disease).
  • Patients with relapsed chronic lymphocytic leukemia with chemosensitive disease at time of transplantation.
  • Patients with lymphoma with chemosensitive disease at the time of transplantation.
  • Planned reduced intensity conditioning regimen.
  • Patients must have a related or unrelated peripheral blood stem cell donor as follows:
    • Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation.
    • Unrelated donor must be a 7/8 or 8/8 match at HLA-A, -B, -C and –DRB1 at high resolution using DNA-based typing. Unrelated donor must be willing to donate peripheral blood stem cells and meet NMDP criteria for donation.
  • Cardiac function: Left ventricular ejection fraction at least 45%.
  • Estimated creatinine clearance acceptable per institutional guidelines.
  • Pulmonary function: DLCO corrected for hemoglobin at least 40% and FEV1 predicted at least 50%.
  • Liver function acceptable per institutional guidelines.
  • Karnofsky Performance Score at least 60%.
  • Female patients (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months post-transplant (see Section 2.6.4 for definition of postmenopausal).
  • Male patients (even if surgically sterilized), of partners of women of childbearing potential must agree to one of the following: practice effective barrier contraception (see Section 2.6.4 for list of barrier methods), or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.
  • Plans for the use of post-transplant maintenance therapy must be disclosed upon enrollment and must be used irrespective of the outcome of the randomization.
  • Voluntary written consent obtained prior to the performance of any study-related procedure that is not a part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.


Exclusion Criteria:

 

  • Prior allogeneic transplant.
  • Active CNS involvement by malignant cells.
  • Patients with secondary acute myeloid leukemia arising from myeloproliferative disease, including CMML.
  • Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
  • Presence of clinically significant fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated.
  • Patients seropositive for human immunodeficiency virus (HIV) with detectable viral load. HIV+ patients with an undetectable viral load on antiviral therapy are eligible.
  • Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
  • Female patients who are pregnant (as per institutional practice) or lactating.
  • Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Patients with prior malignancies except resected non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously must be reviewed and approved by the Protocol Officer or Chairs.
  • Planned use of ATG or alemtuzumab in conditioning regimen.
Drug, Allogeneic peripheral blood stem cell transplant, Drug therapy, Mycophenolate therapy, Tacrolimus therapy
Cancer, Chronic lymphocytic leukemia, Chronic myelogenous leukemia, Graft versus host disease, Leukemia, Myelodysplastic syndromes
Acute leukemia, Allogeneic stem cell transplant, Bone marrow transplant, Cancer treatment, Chemosensitive malignant neoplastic disease, Chronic lymphoid leukemia, disease, Chronic myeloid leukemia, Cyclophosphamide, Graft versus host disease, Hematopoietic system, Medical Oncology, Methotrexate, Mycophenolate mofetil, Tacrolimus, cyclophosphamide, methotrexate, mycophenolate mofetil, tacrolimus
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US Cohort Study of Previously Untreated Patients (PUPs) with Congenital Hemophilia (PUPs Matter) (ATHN 8)

A Study of Previously Untreated Patients (PUPs) with Congenital Hemophilia

Rajiv Pruthi
All
up to 99 years old
This study is NOT accepting healthy volunteers
0000-121905-P01-RST
19-002377
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Inclusion Criteria:

  • Congenital hemophilia A; FVIII ≤ 5% or congenital hemophilia B; FIX ≤ 5%.
  • Birth date on or after January 1, 2010.
  • Care established at one of the participating HTCs.
  • Co-enrollment in the ATHNdataset.
  • Parent or authorized guardian can provide informed consent.


Exclusion Criteria:

  • Patients who are referred to the HTC with no record of bleed and factor utilization data.
Hemophilia
Hereditary factor IX deficiency disease, Hereditary factor VIII deficiency disease
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Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing

A Study to Assess Pulmonary Congestion During Cardiac Hemodynamic Stress Testing

Brandon Wiley
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121917-H01-RST
19-002499
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Inclusion Criteria:
 

  • All adult patients (≥ 18 years old) who are referred for invasive hemodynamic assessment of chronic dyspnea.
  • Patients who have the capacity to understand and consent for the research study.


Exclusion Criteria:
 

  • Patients with known interstitial lung disease or pulmonary fibrosis.
Chronic dyspnea, Pulmonary congestion
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Minimally Invasive Molecular Approaches for the Diagnosis of Barrett’s Esophagus and Esophageal Adenocarcinoma

A Study to Evaluate Minimally Invasive Molecular Approaches for the Diagnosis of Barrett?s Esophagus and Esophageal Adenocarcinoma

Prasad Iyer
All
18 years to 90 years old
This study is NOT accepting healthy volunteers
0000-121933-H01-ALCL
19-002629
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Aim 1

Inclusion Criteria:

  • All participants will be 50 years of age or older and younger than 85 years of age. 
  • All participants will be stratified into those with or without gastroesophageal reflux disease (defined as symptoms of heartburn or acid regurgitation more than once a week, or taking proton pump inhibitors for more than 3 months, or those with the diagnosis of gastroesophageal reflux disease in the diagnostic index, or those with endoscopic evidence of esophagitis).
  • Other risk factors considered would include:
    • Caucasian race;
    • History of ever smoking (current or prior history of smoking);
    • BMI greater than equal to 30;
    •  Family history of Barrett's esophagus or esophageal adenocarcinoma;
    •  Male sex.


Exclusion Criteria:

  • History of Barrett's esophagus or esophageal adenocarcinoma.
  • Prior endoscopy in the last 10 years.
  • Pregnant or lactating females.
  • Patients who are unable to consent.
  • Patients with current history of uninvestigated dysphagia
  • History of eosinophilic esophagitis, achalasia.
  • Patients on oral anticoagulation including Coumadin, Warfarin.
  • Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
  • Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
  • Patients with history of known varices or cirrhosis.
  • Patients with history of esophageal or gastric resection.
  • Patients with congenital or acquired bleeding diatheses.
  • Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
  • Identification of patients meeting inclusion and exclusion criteria was done using two institutional EMR search tools (i2b2 and ACE) using ICD and CPT codes listed below along with NLP for some terms.

Aim 2:

 Inclusion criteria:

  1. Subjects with known BE (cases).
  1. Patient between the ages 18 – 90.
  2. Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
  3. Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
  4. Undergoing clinically indicated endoscopy.
  1. Subjects without known history of BE (controls).
  1. Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria:

a. Subjects with known BE.

  1. Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded.
  2. Patients with history of esophageal or gastric resection. 

b. Subjects with or without known evidence of BE (on history or review of medical records).

  1. Pregnant or lactating females.
  2. Patients who are unable to consent.
  3. Patients with current history of uninvestigated dysphagia (this does not apply to the brushings only portion of the study).
  4. History of eosinophilic esophagitis, achalasia.
  5. Patients on oral anticoagulation including Coumadin, Warfarin.
  6. Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
  7. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
  8. Patients with history of known varices or cirrhosis.
  9. Patients with history of esophageal or gastric resection. 
  10. Patients with congenital or acquired bleeding diatheses.
  11. Patients with a history of esophageal squamous dysplasia.

Aim 3:

Inclusion and exclusion criteria will be those outlined under Aims 1 and 2.

Barrett's esophagus, Cancer, Esophageal cancer, GERD
Adenocarcinoma of esophagus, Barrett's esophagus, Digestive system, Gastroesophageal reflux disease, Medical Oncology
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A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure

A Study to Evaluate the Durability of TD-9855 for Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

Phillip Low
All
30 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-121949-P01-RST
19-002728
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Inclusion Criteria (for 0169 Completers Group): 

  • Subject has completed 4 weeks of double blind treatment in Study 0169 (V6) and, in the opinion of the Investigator, could benefit from continued treatment with TD-9855. No minimum score of OHSA#1 is required to enter V1 of Study 0170. 
  • Subject has a minimum of 80% study medication compliance in Study 0169.
  • The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including an understanding that entry to Study 0170 may result in changes occurring in the subject’s current therapeutic regimen).
  • The subject must be willing to continue on treatment regardless of the possibility of randomization to either TD-9855 or PBO during the randomized withdrawal phase and must continue to meet the inclusion criteria for the preceding study (Study 0169) with the exception that tilt-table test, ESC review and approval of eligibility are not required for entry into Study 0170.

Inclusion Criteria (For De Novo Group): 

  • Subject is male or female and at least 30 years old;
  • Subject must meet the diagnostic criteria of snOH, as demonstrated by a ≥ 20 mm Hg (systolic) or ≥10 mm Hg (diastolic) within 3 min of being tilted-up ≥ 60o from a supine position as determined by a tilt-table test;
  • Subject must score at least a 4 on the OHSA#1 at V1. 
  • For subjects with PD only: Subject has a diagnosis of PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria (1992). 
  • For subjects with MSA only: Subject has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008). 
  • For subjects with PAF only: Subject has impaired autonomic reflexes, as determined by absence of Phase IV BP overshoot after release of the Valsalva strain. 
  • Subject has plasma Norepinephrine (NE) levels ≥ 100 pg/mL after being in seated position for 30 minutes.
  • Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures.
  • Subject is able to communicate well with the Investigator and understand clinic staff, understands the expectations of the study and is able to comply with the study procedures, requirements, and restrictions.

Exclusion Criteria (for 0169 Completers Group): 

  • Subject may not be enrolled in another clinical trial (other than exiting Study 0169).
  • Subject has psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent or interfere with the conduct of the study.
  • Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant. 
  • Uncooperative attitude or reasonable likelihood of non-compliance with the protocol.
  • Subject has a concurrent disease or condition that, in the opinion of the Investigator, would confound or interfere with study participation or evaluation of safety, tolerability, or pharmacokinetics of the study drug.

Exclusion Criteria (For De Novo Group): 

  • Subject has a known systemic illness known to produce autonomic neuropathy, including, but not limited to, amyloidosis and autoimmune neuropathies. Subject has diabetes mellitus and diagnosis of PAF. Subject with diabetes mellitus and either MSA or PD, will be evaluated on a case by case basis by the medical monitor and considered ineligible unless they meet all of the following criteria:
    • Well controlled type-2 DM in treatment with only oral medications and diet;
    • HgbA1C of ≤ 7.5% performed during screening or up to 12 weeks before screening;
    • No clinically evident peripheral neuropathy (e.g., normal sensory examination on peripheral extremities);
    • No known retinopathy (e.g., annual ophthalmic exam is sufficient);
    • No nephropathy (e.g., absence of albuminuria and GFR > 60).
  • Subject has a known intolerance to other NRIs or serotonin norepinephrine reuptake inhibitors (SNRIs).
  • Subject currently uses concomitant antihypertensive medication for the treatment of essential hypertension.
  • Subject has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half-lives, whichever is longer, prior to V1 or requires concomitant use until the follow-up visit.
  • Subject has changed dose, frequency, or type of prescribed medication for orthostatic hypotension within 7 days prior to V1:
    • Midodrine and droxidopa (if applicable) must be tapered off at least 7 days prior to V1. 
  • Subject has known or suspected alcohol or substance abuse within the past 12 months (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR®] definition of alcohol or substance abuse).
  • Subject has a clinically unstable coronary artery disease or has had a major cardiovascular or neurological event in the past 6 months.
  • Subject has used any monoamine oxidase inhibitor (MAO-I) within 14 days prior to V1.
  • Subject has a history of untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the subject.
  • Subject has any significant uncontrolled cardiac arrhythmia.
  • Subject has a Montreal Cognitive Assessment (MoCA) ≤ 23.
  • Subject is unable or unwilling to complete all protocol specified procedures including questionnaires.
  • Subject had a myocardial infarction in the past 6 months or has current unstable angina.
  • Subject has known congestive heart failure (New York Heart Association [NYHA] Class 3 or 4).
  • Subject has had any malignant disease, other than carcinoma in situ of the cervix or basal cell carcinoma, within the past 2 years prior to screening.
  • Subject has a known gastrointestinal (GI) condition, which in the Investigator’s judgment, may affect the absorption of study medication (e.g., ulcerative colitis, gastric bypass).
  • Subject has psychiatric, neurological, or behavioral disorders that may interfere with the ability of the subject to give informed consent or interfere with the conduct of the study.
  • Subject is currently receiving any investigational drug or has received an investigational drug within 30 days of dosing. An investigational drug is defined as drug that is not approved by a regulatory agency (e.g., Food and Drug Administration [FDA]).
  • Subject has a clinically significant abnormal laboratory finding(s) (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3.0 x upper limit of normal [ULN]; blood bilirubin [total] >1.5 x ULN; estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 , or any abnormal laboratory value that could interfere with safety of the subject).
  • Subject has demonstrated a history of lifetime suicidal ideation and/or suicidal behavior, as outlined by the C-SSRS (Baseline/Screening Version). Subject should be assessed by the rater for risk of suicide and the subject’s appropriateness for inclusion in the study.
  • Subject has a concurrent disease or condition that, in the opinion of the Investigator, would confound or interfere with study participation or evaluation of safety, tolerability, or pharmacokinetics of the study drug.
  • Subject has known hypersensitivity to TD-9855 (ampreloxetine hydrochloride), or any excipients in the formulation.
  • Subject has:
    • confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) documented with coronavirus disease 2019 [COVID-19] positive test result; OR
    • is suspected of SARS-CoV-2 infection (clinical features without documented test results two weeks after resolution of symptoms and remains asymptomatic until Day 1); OR
    • has been in close contact with a person with known (or suspected) SARS-CoV-2 infection and remains asymptomatic until Day 1.
  • At V3 (Week 4), following the initial 4-week OL treatment, subjects must demonstrate a reduction in OHSA#1 of at least 2 points compared to the baseline value, as determined in Study 0169 for subjects entering from Study 0169 and from V1 for de novo subjects, in order to continue in Study 0170.
Drug, Drug therapy
Autonomic failure, Multiple system atrophy, Orthostatic hypotension, Parkinson's disease, Pure autonomic failure
Ampreloxetine [USAN], Autonomic nervous system, Cardiovascular system, Multiple system atrophy, Parkinson's variant, Multiple system atrophy, cerebellar variant, Nervous system, Orthostatic hypotension, Parkinson's disease, Pure autonomic failure
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