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3802 Study Matches

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Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing (MODULAR ATP)

Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing

Yongmei Cha
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-307956-P01-RST
22-004324
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Inclusion Criteria:


- Patient who meets Class I, IIa, or IIb guideline ICD indications[i],[ii], or who has
an existing TV-ICD[iii] or S-ICD[iv]

- Patient who is deemed to be at risk for MVT based on at least ONE of the following:

- History of Non-Sustained MVT with LVEF ≤ 50%

- History of sustained VT/VF (secondary prevention) with LVEF ≤ 50% or significant
cardiac scar*

- History of syncope deemed to be arrhythmic in origin

- History of ischemic cardiomyopathy with LVEF ≤ 35%

- History of non-ischemic cardiomyopathy with LVEF ≤ 35% and significant scar*

- Patient who is willing and capable of providing informed consent (which is not to
include the use of a legally authorized representative (LAR) for documentation of
informed consent) and participating in all testing associated with this investigation
at an approved study site and at the intervals defined by this protocol

- Patient who is age 18 years or above, or of legal age to give informed consent
specific to state and national law


Exclusion Criteria:


- Patient with an ongoing complication due to Cardiac Implantable Electronic Device
(CIED) infection or CIED explant

- Transvenous lead remnants within the heart from a previously implanted CIED (Note:
transvenous lead remnants outside the heart (e.g., in the SVC) are allowed)

- Patient with a known LA thrombus

- Patient with a ventricular arrhythmia due to a reversible cause

- Patient indicated for implantation of a dual chamber pacemaker or cardiac
resynchronization therapy (CRT)

- Patient with another implanted medical device that could interfere with implant of the
leadless pacemaker, such as an implanted inferior vena cava filter or mechanical
tricuspid heart valve

- Patient requires rate-responsive pacing therapy

- Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 bpm)

- Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable
Angina) within 40 days

- Inability to access femoral vein with a 21-French (inner diameter)/ 23.5-French outer
diameter) introducer sheath due to known anatomy condition, recent surgery, and/ or
other relevant condition

- Patient who has an active implanted electronic medical device intended for chronic use
concomitantly with the study system, such as a left ventricular assist device (LVAD).
Note that a temporary pacing wire is allowed.

- Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)

- Patient with a known cardiovascular anatomy that precludes implant in the right
ventricle

- Patient with a known allergy to any system components

- Patient with a known or suspected intolerance to S-ICD conversion testing, based on
physician discretion

- Patient is not likely to have meaningful survival** for at least 12 months (documented
or per investigator's discretion)

- Patient is enrolled in any other concurrent study. Co-enrollment into other studies
such as observational studies/ registries needs prior written approval by BSC. Local
mandatory governmental registries are accepted for co-enrollment without approval by
BSC.

- Patient who is a woman of childbearing potential who is known to be pregnant at the
time of study enrollment (method of assessment upon investigator's discretion)

[i]Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with
Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the
American College of Cardiology/American Heart Association Task Force on Clinical
Practice Guidelines and the Heart Rhythm Society. Circulation. (2018); 138:e272-e391.

[ii] 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and
the prevention of sudden cardiac death: The Task Force for the Management of Patients with
Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society
of Cardiology (ESC). European Heart Journal (2015) 36, 2793-2867.

[iii] TV-ICD system is expected to be fully explanted during or prior to full Coordinated
System implant

[iv] Potential subjects with a Model 1010 S-ICD Pulse Generator are only eligible for
MODULAR ATP if they are getting upgraded to Model A209, A219 or future BSC S-ICD Pulse
Generator; Patients with an existing S-ICD PG subject to the electrical overstress field
action are only eligible for MODULAR ATP if they are getting a new BSC Model A209 or A219,
or future BSC S-ICD Pulse Generator

*Significant cardiac scar is defined as a scar involving at least one ventricular
myocardial segment (i.e., basal infero-septum) as identified in the official findings of a
cMRI, or nuclear viability study, or echo report by the interpreting radiologist/
cardiologist who is not affiliated with the study

**meaningful survival means that a patient has a reasonable quality of life and functional
status

Device, Cardiac care management, Implantation of internal cardiac defibrillator
Heart arrhythmia, Ventricular arrhythmia, Ventricular fibrillation, Ventricular tachycardia
History of sustained ventricular fibrillation, History of sustained ventricular tachycardia, Implantable cardioverter-defibrillator insertion, Ventricular tachycardia, monomorphic, Cardiovascular system
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A Pilot and Feasibility Trial of G-POEM for Gastroparesis to Assess Safety, Physiological Mechanisms and Efficacy (G-POEM)

A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis

Michael Camilleri
All
18 years to 70 years old
Phase 1
This study is NOT accepting healthy volunteers
2021-303846-P01-RST
21-001928
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Inclusion Criteria:

  • Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
  • Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
  • Refractory gastroparesis, defined using our previously published data, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3  antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
  • Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75% retained at 2 hours hours or gastric emptying T half greater than 174 minutes. For inclusion, the qualifying gastric emptying scintigraphy will be the baseline gastric emptying test.
  • No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.


Exclusion Criteria:

  • Another active disorder which could explain symptoms in the opinion of the investigator
  • Gastric retention of solids at 4 hours < 25% or < 75% at 2 hours.
  • Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider.
  • Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.
  • Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.
  • New medications for gastroparesis-related symptoms started within 1 month prior to registration.
  • Pregnancy or nursing.
  • Failure to give informed consent.
  • Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
  • Botox injection into the pylorus within 3 months prior to registration.
  • Allergy to eggs or Egg Beaters and Ensure.

Eligibility last updated 12/5/23. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery
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A Real-world Comparative Effectiveness Trial of Treatment Strategies in Patients with Rheumatoid Arthritis: The RA-PRO (Patient Reported Outcomes) Pragmatic Trial (RA-PROPR) (RA-PROPR)

RA-PRO PRAGMATIC TRIAL

Lynne Peterson
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305970-P01-RST
21-009875
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Inclusion Criteria:

  • Prior TNFi biologic treatment – Patient has active, moderate-high disease activity RA (CDAI ≥ 10 and HAQ ≥ 0.5) despite the use/experience for ≥ 3 months of a TNFi-biologic OR discontinued the medication(s) due to intolerability or toxicity irrespective of treatment duration prior to the first dose of study drug; AND
  • Glucocorticoid and NSAID treatment
    •If receiving glucocorticoids (≤ 10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥ 2 weeks prior to randomization; AND
  • Insurance
    •Insurance plan or patient assistance program allows access to at least 1 drug in each of the two treatment strategies for 1 year trial duration. Participants will be allowed to continue their conventional synthetic DMARD (csDMARD) therapy if they had been using it for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, and leflunomide (TNFi-biologic and tsDMARD) through insurance plan or a patient assistance program/plan.


Exclusion Criteria:

  • Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic.
  • Prior treatment with targeted synthetic DMARD.
  • Concomitant use of cyclosporine, or azathioprine within 2-months before randomization.
  • History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD.
  • Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry.
  • Live vaccine within 90 days of study entry.
  • Acute infection treated with parenteral antibiotics or hospitalization within 1 month or with oral antibiotics within 2 weeks of study entry; or chronic infections requiring long-term antibiotic suppressive therapy.
  • History of HIV or opportunistic infections.
  • New York Heart Association Class III or IV heart failure.
  • Latent TB not treated with anti-mycobacterial medication.
  • Untreated Hepatitis B or C infection.
  • History of deep venous thrombosis or pulmonary embolism.
  • Pregnant or nursing women.
  • History of herpes zoster or shingles.

Eligibility last updated 6/1/22. Questions regarding updates should be directed to the study team contact.

Drug
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The 4th Dimension: How Do Our Faces Change Over Time?

Mayo Employee Aging Facial Changes

Basel Sharaf
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308809-H01-RST
22-007357
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Inclusion Criteria:

  • ≥ 18 years of age. 


Exclusion Criteria:
 

  • < 18 years of age.

Eligibility last updated 7/12/22. Questions regarding updates should be directed to the study team contact.

 

 

Age spots
Aging, Change in facial features, Complexion finding, Facial appearance finding, Integumentary system
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Practical assessment of the radiation dose transmitting through the radioprotective garment of pregnant workers in invasive cardiology

A Study of Radiation Dose Transmitting Through the Radioprotective Garments of Invasive Cardiology Workers

Kenneth Fetterly
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309574-H01-RST
22-009917
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Inclusion Criteria:

  • Cardiologists at Mayo Clinic Rochester in Interventional Cardiology, Heart Rhythm Services, Radiology, and Radiation Safety. 


Exclusion Criteria:

  • < 18 years of age. 

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/22/22. Questions regarding updates should be directed to the study team contact.

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BONAPH1DE, A prospective observational study of patients with primary hyperoxaluria type 1 (PH1) (ALN-GO1-007)

BONAPH1DE

John Lieske
All
Not specified
This study is NOT accepting healthy volunteers
2021-305536-P01-RST
21-008615
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Inclusion Criteria:

  •  Documented diagnosis of PH1, per physician’s determination.
  • Written patient consent (per local regulations or ethics committee requirements) obtained prior to enrollment. If the patient is under the age of legal consent, written consent must be obtained from their legal guardian, and the patient should provide assent per local and national requirements. Should they become adults during their participation in the study, they will review and sign the adult consent, as applicable. Consent may be obtained from a legal representative if required and permitted by country-specific regulations or requirements.


Exclusion Criteria:

  • Currently enrolled in a clinical trial for any investigational agent.
Primary hyperoxaluria, type I, lumasiran
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Association between running cadence, 30 second single leg sit to stand test, and stress urinary incontinence during running in parous female athletes.     

Studying the Correlation Between Stress Urinary Incontinence Severity and Running Performance on the 30 Second Sit-to-Stand Test in Post-Partum Female Athletes

Nicole Ron
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-309654-H01-RST
22-010297
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Inclusion Criteria:

  • Healthy, parous, adult volunteers.
  • Self-reported urinary incontinence during running with history of at least one prior delivery after 32 weeks gestation. 
  • Must regularly run at least 10 minutes per week and be pain-free on the day of data collection.


Exclusion Criteria:

  • Unwillingness to complete all components of the study.
  • Urge only urinary incontinence.
  • < 3 months postpartum or current pregnancy.
  • History of prolapse repair.
  • Incontinence surgery.

Eligibility last updated 9/29/22. Questions regarding updates should be directed to the study team contact.

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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Oral Epalrestat Therapy in Pediatric Subjects With Phosphomannomutase 2-congenital Disorder of Glycosylation (PMM2-CDG)

Oral Epalrestat Therapy in Pediatric Subjects With PMM2-CDG

Eva Morava-Kozicz
All
2 years to 17 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-308304-P01-RST
22-005542
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Inclusion Criteria:


1. Age ≥ 2 and < 18 years.

2. Diagnosis of PMM2-CDG, based on molecularly confirmed biallelic PMM2 pathogenic variants (can be historical diagnosis with lab report on file).

3. Informed consent (and assent, as applicable) document personally signed by the legally authorized representative of the patient, indicating that the patient's parent/guardian has been informed and agreed to all aspects of the study.

4. Be willing and able to adhere to the study assessments and schedule described in the protocol and consent/assent documents.

5. Negative urine pregnancy test (only for female subjects of child-bearing potential)

6. For subjects of child-bearing potential-only, subject has been counseled on and agrees to the requirement either for double barrier contraceptive methods and/or for total
abstinence from prior to randomization through 3-months after the cessation of treatment.


Exclusion Criteria:


1. Known or suspected other known CDG.

2. Known allergy to aldose reductase inhibitors.

3. Hypersensitivity to epalrestat.

4. Hepatic impairment defined as any one of the following:

1. AST/ALT > 5 x ULN in the 6 months prior to screening;

2. Bilirubin > 2 x ULN in the last 6 months prior to screening;

3. Synthetic liver dysfunction (albumin deficiency < 2.8 mmol/L) at screening; or

4. Diagnosis of liver fibrosis (Fibroscan > 7 kPa) confirmed by liver elastogram at screening;

5. Renal impairment defined as serum creatinine: > 0.5 mg/dL (≤ 6 years); > 0.7 mg/dL (7-10 years); > 1.24 mg/dL (≥ 11 years);

6. Low platelet count (< 125x10^9 /L);

7. Any other clinically significant lab abnormality which, in the opinion of the investigator, should be exclusionary;

8. Anemia (Hgb < 10 g/dL);

9. Use of an investigational drug, including acetazolamide, in the past 28 days; use of an investigational biologic in the past 12 months;

10. Concurrent or planned participation in interventional protocol or use of any other unapproved therapeutics; and

11. Any other medical condition, which, in the opinion of the investigator, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.

Drug, Other
Congenital disorder of glycosylation type Ia
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Characteristics and Patient-Clinician Communication during Cardiology Telemedicine Clinical Encounters: Opportunities for Intervention

Patient-Clinician Racial and Ethnic Differences during Cardiology Telemedicine

Adam Milam
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309707-H01-RST
22-010489
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Inclusion Criteria:

  • Patients will be recruited from the random sample of cardiologists  with the goal of oversampling racial minorities and other underserved populations.
  • Cardiologists from the Mayo Clinic Department of Cardiovascular Medicine will be randomly selected to participate in the proposed study.
  • Patients of participating cardiologists will be recruited to form patient-clinician dyads.


Exclusion Criteria:
 

  • < 18 years of age. 

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/4/22. Questions regarding updates should be directed to the study team contact.

 

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Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma

A Study Identifying Predictive Biomarkers for the Progression of Invasive Squamous Cell Carcinoma

Dennis Wigle
All
18 years and over
This study is NOT accepting healthy volunteers
0000-117257-H01-RST
15-000548
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Inclusion Criteria

  • known or suspected squamous cell carcinoma of the lung
  • able to provide consent
  • could have already had a bronchoscopy or surgical resection with tissue saved at the Mayo Clinic Rochester
  • will be undergoing a bronchoscopy and having a surgical resection at the Mayo Clinic Rochester

 

Exclusion Criteria

  • unable to provide consent
  • pregnant

 

Cancer, Lung cancer, Squamous cell carcinoma of the skin
Bronchoscopy, Integumentary system, Medical Oncology, Respiratory system, Squamous cell carcinoma of bronchus, Squamous cell carcinoma of lung
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STABILITY 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs. Quad Tendon

STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon

Aaron Krych
All
14 years to 25 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307774-P01-RST
22-003466
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Inclusion Criteria:


- Age 14-25.

- An ACL-deficient knee.

- Skeletal maturity (i.e., closed epiphyseal growth plates on standard knee radiographs).

- At least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity (Beighton score
of ≥ 4) and/or genu recurvatum > 10 degrees.


Exclusion Criteria:


- Previous ACLR on either knee.

- Partial ACL injury (defined as one bundle ACL tear requiring
reconstruction/augmentation of the torn bundle with no surgery required for the intact
bundle).

- Multiple ligament injury (two or more ligaments requiring surgery).

- Symptomatic articular cartilage defect requiring treatment other than debridement.

- > 3 degrees of asymmetric varus.

- Inflammatory arthropathy.

- Inability to provide consent.

- Pregnancy at baseline.

Eligibility last updated 9/23/22. Questions regarding updates should be directed to the study team contact.

 

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ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer

ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC) (ACT-MBC)

Karthik Giridhar
All
18 years and over
This study is NOT accepting healthy volunteers
2020-302848-P01-RST
21-001745
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Inclusion Criteria:

  • Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease 2 ER+/HER2- patients prior to starting 2nd line therapy or beyond in the metastatic setting OR ER/PR/HER2-negative (Triple Negative) patients prior to starting any line of therapy in the metastatic setting.
  • Note: ER/PR/HER2 status is defined per the 2018 ASCO/CAP guidelines as follows: ER-positive and PR-positive is defined as ≥ 1% reactive cells by immunohistochemical staining. HER2 Negative Disease is defined by meeting one of the following criteria:
    • 0 or 1+ by IHC and not amplified by ISH;
    • 0 or 1+ by IHC and ISH not done;
    • 2+ by IHC and ISH results are:
      • < 6.0 HER2 signals/cell with HER2/CEP17 ratio < 2.0;
    • IHC not done and not amplified by ISH.
  • Measurable and/or non-measurable disease is allowed.
  • Male or female breast cancer is allowed.
  • Age > 18 years.
  • Willingness to provide mandatory blood specimens.
  • Willing to return to enrolling institution for follow up imaging at least once.


Exclusion Criteria:

  • Life expectancy of ≤ 6 months.
  • Inability to provide blood samples based on the judgment of the treating provider.

Eligibility last updated 12/20/23. Questions regarding updates should be directed to the study team contact.

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MK-1026-003: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Sameer Parikh
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304753-P01-RST
21-005473
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Inclusion Criteria:


- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to allocation

- Has a life expectancy of at least 3 months, based on the investigator assessment

- Has the ability to swallow and retain oral medication

- Participants who are Hepatitis B surface antigen (HBsAg)-positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have
undetectable HBV viral load prior to randomization

- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

- Has adequate organ function

- Male participants agree to refrain from donating sperm and agree to either remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle OR
agree to use contraception, during the intervention period and for at least the time required to eliminate the study intervention after last dose of study intervention

- Female participants assigned female sex at birth who are not pregnant or breastfeeding are eligible to participate if not a participant of childbearing potential (POCBP), or
if a POCBP they either use a contraceptive method that is highly effective OR remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle during the intervention period and for at least 30 days after the last dose of study intervention

- Participants with HIV are eligible if they meet all of the following: the CD4 count is >- 350 cells/uL at screening, the HIV viral load is below the detectable level, are on a
stable ART regimen for at least 4 weeks prior to study entry, and are compliant with their ART

Part 1 and Part 2 (Cohorts A to C)

- Has a confirmed diagnosis of CLL/SLL with

- At least 2 lines of prior therapy (Part 1 only)

- Part 2 Cohort A: CLL/SLL participants who are relapsed or refractory to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi), and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines

- Part 2 Cohort B: CLL/SLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment naive

- Part 2 Cohort C: CLL/SLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy

- Has active disease for CLL/SLL clearly documented to initiate therapy

- Has evaluable core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate at Screening (optional for participants enrolling in Part 1)

Part 2 (Cohorts D to G)

- Has a confirmed diagnosis of and response to previous treatment of one of the following:

- Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D)

- Participants with pathologically confirmed MCL, documented by either overexpression of cyclin D1 or t(11;14), who are relapsed or are refractory to
chemoimmunotherapy and a covalent irreversible BTKi (Cohort E)

- Participants with MZL (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to chemoimmunotherapy and a covalent irreversible BTKi
(Cohort F)

- Participants with FL who are relapsed or refractory to chemoimmunotherapy, immunomodulatory agents (i.e., lenalidomide plus rituximab) (Cohort G)

- Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan

- Has a lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate (Cohort D) at Screening

Part 2 (Cohort H): confirmed diagnosis of WM; participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi

- Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease

- Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement
must be > 15 mm in the longest diameter or >10 mm in the short axis); IgM ≥ 450 mg/dL; or bone marrow infiltration of 10%

- Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at Screening or a lymph node biopsy from an archival


Exclusion Criteria:


- Has active HBV/HCV infection (Part 1 and Part 2)

- Has a history of malignancy ≤ 3 years before providing documented informed consent. Participants with basal cell carcinoma of skin, squamous cell carcinoma of skin, or
carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy are not excluded. Participants with low-risk, early-stage prostate cancer (T1-T2a, Gleason score ≤ 6, and prostate-specific antigen < 10 ng/mL) either treated with definitive intent or untreated in active surveillance with SD are not excluded

- Has active central nervous system (CNS) disease

- Has an active infection requiring systemic therapy

- Has received prior systemic anti-cancer therapy within 4 weeks prior to allocation

- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention

- Has any clinically significant gastrointestinal abnormalities that might alter absorption

- History of severe bleeding disorders

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/4/23. Questions regarding updates should be directed to the study team contact.

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Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Placebo-controlled Pilot Trial (MC211003)

Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy

Mina Hanna
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305219-P01-ALCL
21-011969
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Registration

Inclusion Criteria:

  • Age ≥ 18 years.
  • English speaking.
  • Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy.
  • At least 4 out of 10 severity of neuropathy pain and/or tingling per appendix IV.
  • Stable for at least 7 days prior to registration [SJB1] [LCLM2] [GAM3] on medications for neuropathy, if any are being used.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
    • NOTE: If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Able to provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • No evidence of residual cancer.
  • Required Initial Laboratory Values: Following completion of chemotherapy, patients must have had a CBC and serum chemistries, including the following:
      • Platelet count > 100,000/mm^3;
      • Absolute neutrophil count (ANC) ≥ 1,000/mm^3;
      • Hemoglobin > 11 g/dL;
      • Serum transaminase [ALT or AST] ≤ 1.2 x upper limit of normal (ULN);
      • Alkaline phosphatase ≤ 1.2 x ULN;
      • Serum creatinine ≤ 1.2 x ULN.

Registration


Exclusion Criteria:

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Any medical condition that would prohibit use of a topical cream (skin infection or open wound in the area of the neuropathy).
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Pre-existing neuropathy prior to chemotherapy that would confuse the issue of CIPN.
  • Currently on chemotherapy or received chemotherapy treatment within the prior 3 months.
  • Use of other cannabis products within 30 days prior to registration.
  • History of allergy to cannabis products.

Crossover Re-Registration –

Inclusion Criteria:

  • Treatment cannot begin prior to registering to the crossover phase and will ideally begin ≤ 7 days after registration for the crossover phase.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

 

Behavioral, Drug, Other
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Mayo Clinic Health System — Albert Lea, MN

A Pilot Trial of an Early Cognitive Intervention for Children Undergoing Proton Radiation for Brain Tumors

Intervention for Children Undergoing Proton Radiation for Brain Cancer

Yu Shi
All
4 years to 75 years old
This study is NOT accepting healthy volunteers
2022-307906-P01-RST
22-004238
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Inclusion Criteria:

  • The study participants will be recruited in the proton radiation therapy (PRT) facility of Mayo Clinic Rochester.
  • Children between the age of 4 and 10 years with brain tumors annually.
  • This age range is chosen as:
    • Suitable for our intervention program;
    • Appropriate for the chosen assessments;
    • Compatible with ages associated with long-term neurocognitive deficits in prior studies.


Exclusion Criteria:

  • Expected survival less than a year.
  • Child or parent unable to speak or understand English.
  • Child unable to participate in major components of the intervention due to severe limitations in visual/auditory abilities or mobility. 
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First-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets

Shaji Kumar
All
19 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307902-P01-RST
22-003988
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Inclusion Criteria:


- Eastern Cooperative Oncology Group (ECOG) performance status <= 1.

- Laboratory values meeting the criteria outlined in the protocol.

- Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria.

- Has measurable disease at screening as defined in the protocol.

- Locally documented or centrally determined t(11;14) positive status and/or centrally determined BCL2high status.

Note: If local testing for t(11;14) is discordant with central testing for t(11;14) status, a detailed review of central and local results for t(11;14) status is required to ensure the participants' safety.

- Refractory to or intolerant of all established MM therapies that are known to provide clinical benefit and received all standard of care (SOC) agents in previous line(s) of
therapy, including a proteasome inhibitors (PI), an Immunomodulatory drugs (IMID), and an anti-CD38 monoclonal antibody.

- Permitted to be venetoclax or BCL-2 inhibitor exposed in previous lines of therapy.

- Life expectancy >= 12 weeks.


Exclusion Criteria:


- Clinically relevant or significant Electrocardiogram (ECG) abnormalities as outlined in the protocol.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/12/23. Questions regarding updates should be directed to the study team contact.

Drug
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A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors (TRUST-II)

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

Anastasios Dimou
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306818-P01-RST
22-000109
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Inclusion Criteria:


1. Age ≥18 years (or ≥20 years as required by local regulations).

2. Histologically or cytologically confirmed diagnosis of locally advanced (including
inoperable Stage IIIA or IIIB NSCLC) or metastatic NSCLC or other solid tumors.

3. Evidence of ROS1 fusion by a validated assay.

4. Patients with central nervous system (CNS) involvement, including leptomeningeal
carcinomatosis, must be stable, either asymptomatic or previously treated and
controlled within 14 days of first dose.

5. The patient can be either ROS1 TKI treatment naïve or treated with prior ROS1 TKI(s).

6. The patient must have at least 1 measurable disease per RECIST 1.1 as assessed by the
investigator.

7. Eastern Cooperative Oncology Group Performance Status: 0 or 1.

8. Patient with a life expectancy ≥12 weeks based on the judgement of investigator.

9. Patients with adequate organ function meeting the following criteria:

1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤3.0 × upper
limit of normal (ULN) (or ≤5.0 × ULN, for patients with concurrent liver
metastases)

2. Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for patients with Gilbert syndrome
or if liver function abnormalities are due to underlying malignancy)

3. Absolute neutrophil count: ≥1,500/?L

4. Platelet count: ≥100,000/?L

5. Hemoglobin: ≥9.0 g/dL

6. Serum creatinine ≤1.5 × ULN

10. Patients must be able to practice required contraception during the study.

1. For males (irrespective of surgical sterilization [vasectomy]): agree to use
effective contraception methods during the study intervention period and for at
least 90 days after the last dose of investigational drug or agree with complete
abstinence.

2. Females without menses for at least 1 year prior to screening or documented to be
surgically sterilized. Women of childbearing potential (WOCBP) must agree to use
two concurrent highly effective methods of contraception or agree with complete
abstinence from sexual intercourse since the informed consent until 45 days after
the last dose of investigational drug. The patient is willing and capable to give
written informed consent.

11. The patient is willing and capable to comply with the study scheduled visits,
treatment plans, laboratory tests and other procedures.

12. The patient is willing and capable to comply with study site's COVID-19 policies.

Exclusion Criteria

1. Treatment with small molecule anticancer therapy including other investigational
agents or cytotoxic systemic anticancer therapy within 2 weeks (or 5 half-lives of the
compound, whichever is shorter) prior to the first dose of taletrectinib; Treatment
with immuno-oncology (IO) including immune checkpoint inhibitors within 4 weeks before
the first dose of taletrectinib.

2. Major surgical procedure, open biopsy, or significant traumatic injury ≤4 weeks before
the first dose of taletrectinib.

? Placement of vascular access device is not considered major surgery. Other minor
surgical procedures, such as catheter placement or minimally invasive biopsy, are
allowed.

3. Radiotherapy within 14 days before study treatment. Stereotactic radiosurgery (SRS),
stereotactic radiation therapy (SRT), and palliative radiation outside the chest and
brain are allowed but must be completed 1 week before starting study treatment.

4. Have been diagnosed with another primary malignancy other than NSCLC except for
adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively
treated non-metastatic prostate cancer; or patients with another primary malignancy
who are definitively relapse-free with at least 3 years elapsed since the diagnosis of
the other primary malignancy. Note: This criterion does not apply to patients to be
enrolled in Cohort 4.

5. Adverse events due to prior therapy are unresolved to ≤ CTCAE Grade 1 or has not
returned to baseline, by the first dose of taletrectinib except for AEs not
constituting a safety risk to the patient based on the judgment of investigators.

6. Patients with untreated spinal cord compression caused by tumor and/or cancerous
meningitis.

7. History or evidence of interstitial fibrosis, interstitial lung disease or
drug-induced pneumonitis.

8. Any gastrointestinal disorders that may affect absorption of oral medications.

9. Active and clinically significant bacterial, fungal, or viral infection including
hepatitis B virus (HBV), hepatitis C virus (HCV), or severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2), known human immunodeficiency virus (HIV) or acquired
immunodeficiency syndrome (AIDS)-related illness.

10. Clinically significant cardiovascular diseases within 3 months prior to the first dose
of taletrectinib: myocardial infarction, severe/unstable angina, coronary/peripheral
endovascular treatment, heart failure or cerebrovascular disorder including transient
ischemic attack.

11. Ongoing cardiac dysrhythmias of ≥ CTCAE Grade 2, uncontrolled atrial fibrillation of
any grade, or QT interval corrected for heart rate by Fredericia's formula (QTcF) >470
milliseconds, or symptomatic bradycardia <45 beats per minute; patient has family or
medical history of long QT syndrome.

12. Pregnancy or lactation/breastfeeding.

13. Use of food or drugs that are known potent cytochrome P450 3A4/5 (CYP3A4/5) inhibitors
or inducers or P-glycoprotein inhibitors or inducers within 14 days prior to the first
dose of study treatment and while on treatment.

14. Administration of agents with potential QT interval prolonging effect within 14 days
prior to first dose of study treatment and while on treatment.

15. Patients with other severe medical or mental diseases in whom the risk is increased by
the participation to the study or treatment with study treatment in the opinion of the
investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/9/23. Questions regarding updates should be directed to the study team contact.

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Endocrine Therapy-Induced Alopecia Natural History Evaluation among Female Breast Cancer Survivors

Natural History Evaluation Among Female Breast Cancer Survivors with Endocrine Therapy-Induced Alopecia

Elizabeth Cathcart-Rake
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-307712-P01-RST
22-004341
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Registration
•Inclusion Criteria

  • Age ≥ 18 years
  • Women with a diagnosis of breast cancer who are being treated with curative intent, with the one exception being women who are receiving CDK4/6 inhibitors (these patients being allowed to have more advanced disease).
  • Provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Filling into one of the 5 groups discussed in section 5.0 (understanding that groups will close once they complete their accrual goals of 30 patients.
  • Willingness to complete questionnaires every 3 months.
  • Ability to complete the first questionnaire within 2 weeks of therapy initiation (for the four arms that are receiving adjuvant hormonal therapy).

Registration
•Exclusion Criteria

  • Verbal baseline alopecia ≥ 2 on an 11 point scale (from none=0 to severe=10).   The question to use for this item is: Please rate your hair thinning or loss on a scale from 0 to 10, with 0 being no hair loss and 10 being complete hair loss.
  • Planned receipt of chemotherapy or another cancer-directed therapy concurrently (e.g., everolimus, etc.; note that a CDK4/6 inhibitor is allowed within cohort 3).
  • Prior use of endocrine therapy for breast cancer.
  • Receipt of chemotherapy over the previous 6 months.

Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.

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Registry of Asthma Patients Initiating DUPIXENT® (RAPID) (RAPID)

Registry of Asthma Patients Initiating DUPIXENT®

Joseph Skalski
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308615-P01-RST
22-006735
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Inclusion Criteria:

- Willing and able to comply with the required clinic visits, study procedures and assessments.
- Able to understand and complete study-related questionnaires.
- Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required.
- Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information.


Exclusion Criteria:

- Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information.
- Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
- Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.

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Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (SSB 11-02)

A Study to Evaluate the Safety and Effectiveness of the GORE® TAG® Thoracic Branch Endoprosthesis for Treating Lesions of the Aortic Arch and Chest Aorta

Randall DeMartino
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-118623-P01-RST
16-004194
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Inclusion Criteria:

All Subjects

  • Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2:
    • Aneurysms:
      • Fusiform aneurysm (≥ 55 mm); or
      • Fusiform aneurysm (> 2 times native aortic diameter); or
      • Saccular aneurysm (no diameter criteria).
    • Non-aneurysms
      • Intramural hematoma (no diameter criteria); or
      • Penetrating aortic ulcer (no diameter criteria); or
      • Traumatic aortic transection (no diameter criteria); or
      • Other isolated lesion with non-diseased proximal and distal landing zone, or Type B aortic dissection requiring treatment for rupture or impending rupture, malperfusion syndrome, rapid expansion, uncontrollable pain, aneurysmal dilatation or prophylactic reasons; or
      • Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment. TBE implant must be at least 14 days after the surgical repair procedure.
  • Age ≥ 18 years at time of informed consent signature.
  • Subject is capable of complying with protocol requirements, including follow-up.
  • Informed Consent Form (ICF) is signed by Subject or legal representative.
  • Must have appropriate proximal aortic landing zone, defined as:
    • Requires placement of the proximal extent of the Aortic Component in Zone 0-2 for exclusion of the lesion.
    • Acceptable proximal landing zone outer curvature length for the required device.
    • Landing zone inner diameters between 16-48 mm in Zone 1-2 Subjects and 24-48 mm in Zone 0 Subjects.
    • Landing zone includes either the brachiocephalic, left common carotid or left subclavian native ostium.
      • If the landing zone includes brachiocephalic it cannot be heavily calcified or heavily thrombosed;
      • If the landing zone includes either the left common carotid or left subclavian it cannot be heavily calcified, heavily thrombosed or aneurysmal.
    • Dissection Patients: Primary entry tear must be distal to the target branch vessel and proximal extent of the proximal landing zone must not be dissected.
    • For patients with prior replacement of the ascending aorta and/or aortic arch by a surgical graft, there must be at least 2 cm of landing zone proximal to the most distal anastomosis site.
  • Must have appropriate target branch vessel landing zone, defined as:
    • Length of ≥ 3 cm proximal to first major branch vessel if using Aortic Component with 8 mm portal diameter; or
    • Length of ≥ 2.5 cm proximal to first major branch vessel if using Aortic Component with 12 mm portal diameter (required for Zone 0 Subjects);
    • Target branch vessel inner diameters of 6-15 mm if using Aortic Component with 8 mm portal diameter; or
    • Inner diameters of 11-18 mm if using Aortic Component with 12 mm portal diameter (required for Zone 0 Subjects);
    • Target branch vessel landing zone must be in native aorta that cannot be severely tortuous (i.e., vessel tortuosity that results in a 180 degree turn within the treated target branch vessel length), aneurysmal, dissected, heavily calcified, or heavily thrombosed.
  • For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone, defined as:
    • Outer curvature length must be ≥ 2 cm proximal to the celiac artery;
    • Aortic inner diameters between 16-48 mm (diameter should be between 16-42 mm if using distal CTAG Device extension);
    • Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed;
    • Landing zone in native aorta or previously implanted Conformable GORE® TAG® Device.

Zone 0/1 Subjects Only

  • Subject does not have a mechanical aortic valve.
  • Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator.


Exclusion Criteria:

All Subjects

  • Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair.
  • Previous endovascular repair of the ascending aorta.
  • Previous endovascular repair of the DTA with a non-Gore device.
  • Surgery within 30 days prior to enrollment with the exception of:
    • Surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access;
    • Surgery to treat any other presenting injuries in Traumatic Transection subjects only.
  • Infected aorta.
  • Life expectancy < 2 years.
  • Myocardial infarction within 6 weeks prior to treatment.
  • Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.
  • Patient has an active systemic infection (e.g. infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection. Patients with a chronic infection (such as HIV, Hepatitis C, etc.) that is well controlled under their current treatment regimen may be eligible.
  • Pregnant female at time of informed consent signature.
  • Degenerative connective tissue disease; e.g., Marfan’s or Ehler-Danlos Syndrome.
  • Participation in another drug or medical device study within one year of study enrollment.
  • Known history of drug abuse within one year of treatment.
  • Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta.
  • Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access.
  • Planned coverage of celiac artery.
  • Patient has known sensitivities or allergies to the device materials.
  • Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
  • Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin.
  • Patient with a history of a hypercoagulability disorder and/or hypercoagulability state.
  • Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper.
  • Mycotic aneurysm.
  • Persistent refractory shock (systolic blood pressure < 90 mm Hg).
  • Patient has body habitus or other medical condition which prevents adequate visualization of the aorta.
  • Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) < 30 (ml/min/1.73 m2) or currently requiring dialysis.

Zone 0/1 Subjects Only

  • Patient at high risk for a neurological event; e.g., stroke.

 

 

 

Zone 0/1 Subjects Only:

Device, Endoscopy of aorta, Fluoroscopy guided endovascular repair of thoracic aortic aneurysm with contrast
Aneurysm of thoracic aorta, Dissection of thoracic aorta, Ectasia of thoracic aorta
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AL-DES-01; RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients With Progressing Desmoid Tumors (RINGSIDE)

A Study to Evaluate AL102 to Treat Patients with Progressing Desmoid Tumors

Scott Okuno
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2021-305026-P01-RST
21-006448
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Inclusion Criteria
•Part A:

  • At least 18 years of age (inclusive) at the time of signing the ICF.
  • Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist (prior to informed consent) that has progressed by ≥ 20% as measured by RECIST v1.1 within 12 months of the screening visit scan.
  • At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part A only).
  • One of the following:
    • Treatment naïve subjects whose disease is not amenable to surgery without the risk of significant morbidity; OR
    • Recurrent/refractory disease following at least one line of therapy (including surgery, radiation, or systemic therapy).
  • A desmoid tumor in which continued progressive disease will not result in immediate significant risk to the subject.
  • Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for re-confirmation of disease.
  • Must be able to swallow whole capsules with no GI condition affecting absorption; nasogastric or G-tube administration is not allowed.

Exclusion Criteria
•Part A:

  • Diagnosed with a malignancy in the past 2 years.
  • Current or recent (within 2 months of IP administration) GI disease or disorders that increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
  • Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of IP such as known active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at Screening.
  • Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, , symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic evidence of acute ischemia.
  • Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the subject associated with his or her participation in the study.
  • Pregnant or breastfeeding or expecting to conceive children within the projected duration of the study.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
  • Abnormal organ and marrow function at Screening defined as:
    • Neutrophils < 1000/mm^3;
    • Platelet count < 100,000/mm^3;
    • Hemoglobin < 9 g/dL;
    • Total bilirubin > 1.5 x upper limit of normal (ULN) (except known Gilbert's syndrome);
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x ULN;
    • Serum creatinine > ULN and creatinine clearance (CrCl) < 60 mL/min (calculation of CrCl will be based on acceptable institution standard).
  • Uncontrolled triglyceride ≥ Grade 2 elevations per common terminology criteria for adverse events (CTCAE) v5.0 (> 300 mg/dL or > 3.42 mmol/L).

ECG Exclusions (Part A only):

  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 450 mse.
  • QRS duration > 110 ms.
  • PR interval > 240 ms.
  • Marked ST-T wave abnormalities which would make it difficult to measure the QT interval.
  • Any treatments for desmoid tumors within 4 weeks prior to first dose of investigational therapy; subject must have recovered from therapy related toxicity to < CTCAE Grade 2 or clinical baseline. Therapy includes:
    • Locoregional tumor directed therapies such as major surgery, radiation, radiofrequency ablation, or cryosurgery;
    • Systemic therapy including chemotherapy, biologic (anti-neoplastic agent, antibodies), TKIs (e.g., sorafenib, pazopanib, imatinib), hormonal therapy, or investigational therapy.
  • Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP.

Inclusion Criteria
•Part B:

  • ≥ 12 years of age (inclusive) and ≥ 40 kg at the time of signing the ICF.
  • Evidence of measurable disease by CT/MRI scan. Measurable lesions are defined according to RECIST v1.1.
  • Subject and/or legally authorized representative (i.e., parent/guardian) must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF.
  • Minor subjects must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements).
  • For all other inclusion criteria refer to Part A inclusion criteria.

Exclusion Criteria
•Part B:

  • The subjects must be excluded from participating in the study if they meet any of the exclusion criteria for Part A, except where otherwise noted.
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ARST2032, A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma

Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma

Wendy Allen-Rhoades
All
up to 21 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-309451-P01-RST
22-009627
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Inclusion Criteria:


- All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular
Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032
(this trial).

- Patients must be ≤ 21 years at the time of enrollment.

- Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle
cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS)
(institutional FOXO1 fusion results are acceptable). RMS types included under ERMS
include those classified in the 1995 International Classification of Rhabdomyosarcoma
(ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified
in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and
botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical
spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment
in APEC14B1 is required for all patients.

- All patients will be evaluated for stage and clinical group. Note that clinical
group designation assigned at the time of enrollment on study remains unchanged
regardless of any second-look operation that may be performed.

- Patients will be eligible for the very low-risk stratum (Regimen VA) if they
have Stage 1, CG I disease.

- Patients will be eligible for the low-risk stratum (Regimen VAC/VA) if they
have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III
(orbit only) disease.

- Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling
(SIRLNS) is required for all patients ≥ 10 years of age with paratesticular
tumors who do not have gross nodal involvement on imaging.

- Extremity Tumors: Regional lymph node sampling is required for histologic
evaluation in patients with extremity tumors.

- Clinically or radiographically enlarged nodes must be sampled for histologic
evaluation.

- Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for
patients > 16 years of age) performance status score of ≥ 50. Patients who are unable
to walk because of paralysis, but who are up in a wheelchair, will be considered
ambulatory for the purpose of assessing performance score.

- Peripheral absolute neutrophil count (ANC) ≥ 750/uL (within 7 days prior to
enrollment).

- Platelet count ≥ 75,000/uL (transfusion independent) (within 7 days prior to
enrollment).

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70
mL/min/1.73 m^2 or a serum creatinine (within 7 days prior to enrollment) based on
age/gender as follows:

- Age: 1 month to < 6 months; Maximum serum creatinine (mg/dL): 0.4 (male) : 0.4
(female);

- Age: 6 months to < 1 year; Maximum serum creatinine (mg/dL): 0.5 (male) : 0.5
(female);

- Age: 1 to < 2 years; Maximum serum creatinine (mg/dL): 0.6 (male) : 0.6 (female);

- Age: 2 to < 6 years; Maximum serum creatinine (mg/dL): 0.8 (male) : 0.8 (female);

- Age: 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 (male) : 1 (female);

- Age: 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 (male) : 1.2
(female);

- Age: 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 (male) : 1.4
(female);

- Age ≥ 16 years; Maximum serum creatinine (mg/dL): 1.7 (male) : 1.4 (female);

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to
enrollment); and

- If there is evidence of biliary obstruction by the tumor, then the total
bilirubin must be < 3 x ULN for age.

- Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the
value of 45 U/L.

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135
U/L (within 7 days prior to enrollment).

- All patients and/or their parents or legal guardians must sign a written informed
consent.

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met.


Exclusion Criteria:


- Patients who have received prior chemotherapy and/or radiation therapy for cancer
prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.

- Patients who have received chemotherapy or radiation for non-malignant conditions
(e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for
non-malignant conditions prior to starting protocol therapy.

- Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have
received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7
days prior to study enrollment.

- Patients unable to undergo radiation therapy, if necessary, as specified in the
protocol.

- Evidence of uncontrolled infection.

- Female patients who are pregnant since fetal toxicities and teratogenic effects have
been noted for several of the study drugs. A pregnancy test is required for female
patients of childbearing potential.

- Lactating females who plan to breastfeed their infants.

- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/9/22. Questions regarding updates should be directed to the study team contact.

Drug, Biologic/Vaccine, Radiation
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Mayo Clinic — Rochester, MN

A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD) - PHANTOM Study (PHANTOM)

A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)

Keith Baratz
All
30 years to 75 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-308134-P01-RST
22-004806
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Inclusion Criteria:


- Male or female diagnosed with FECD.


Exclusion Criteria:


- Females who are pregnant or lactating.

- Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemet stripping
endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK),
Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only
(DSO) in the study eye.

Drug, Other
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Mayo Clinic — Rochester, MN

A Phase 1 Open Label Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PHIN-214 in adults with Child Pugh A and B Cirrhosis (PharmaIN)

Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics

Douglas Simonetto
All
18 years to 75 years old
Phase 1
This study is NOT accepting healthy volunteers
2022-307414-P01-RST
22-002190
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Inclusion Criteria:


1. Body mass index within the range 18 to 40 kg/m^2 (inclusive) at screening.

2. Females must be non-pregnant, non-lactating or of non-childbearing potential or using highly efficient contraception for the full duration of the study.

3. Cirrhosis based on histology or a combination of clinical, radiological, or biochemical and classified as Child-Pugh A or B.


Exclusion Criteria:


1. Significant abnormalities in medical history or on physical examination, including:   respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities.

2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.

3. Significant kidney disease.

4. Estimated glomerular filtration rate (eGFR by CKD-Epi) < 60 ml/min/1.73 m^2 or Cr > 2.0 mg/dL.

5. Hepatic encephalopathy > grade 2 in the previous 3 months. Stable drug treatment for HE is not exclusionary.

6. Recipient of a transjugular intrahepatic portosystemic shunt (TIPS).

7. Known positive HIV serology confirmed by HIV viral load.

8. Subjects with acute infections, including acute viral hepatitis are to be excluded.  Subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3
months prior to study inclusion.

Eligibility last updated 8/23/23. Questions regarding updates should be directed to the study team contact.

Drug
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Mayo Clinic — Rochester, MN

Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet

All
25 Years to 70 Years old
Early Phase 1
This study is NOT accepting healthy volunteers
NCT05658263
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Inclusion Criteria:

• Age 25-70 years
• Primary diagnosis of colon cancer, stages 1-3.
• Able and willing to provide informed consent.
• English-speaking.
• Willingness to return to the study site for specified study visits at D7 and D30.
• Able to comply with study measures.
Exclusion Criteria:

• Age ≤ 25 years or ≥70 years
• If surgery is being performed for any reason other than resection of colon cancer. Neoadjuvant therapy, or if surgery is not the initial approach for the patient's colon cancer treatment
• Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy: any personal history of hereditary or acquired bleeding disorder, or thrombocytopenia with platelets under 100,000.
• Serum creatinine greater than 1.5 mg/dL.
• Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome or alkaline phosphatase or ALT or AST greater than 2.5 times the upper limit of normal. Elevated INR (1.5 or above).
• Alcohol intake more than one drink or greater than 20 grams per day for women or 30 grams per day for men.
• History of gastrointestinal surgery including stomach, small bowel or colon resection, pancreatic surgery, bile duct or gallbladder surgery, or splenectomy, or gastric bypass.
• History of intra-abdominal sepsis.
• Previous organ transplantation.
• Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
• Currently pregnant or nursing.
• History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
• Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
• Depression: A CES-D score more than 16 and a psychologist determining that the patient is not a good fit for surgery.
• Body mass index (BMI) <20 or > 40 kilograms per meter squared: obesity is known to impact the microbiome and immune system and the occurrence of anastomotic leak, and extreme obesity may confound interpretation of these factors in association to leak. Inferences may be made by matching participants with less severe obesity (BMI <40).
• Presence of any type of non-MRI compatible implant, including cardiac pacemakers or defibrillators, neurostimulators, cochlear implants, or other metallic hardware
• Self-reported history of claustrophobia.
• Incarceration
• Inability to adhere to the study protocol, procedures, and diet
• Exclusions may also be made at the discretion of the attending physician.
Dietary Supplement: Standard Diet, Dietary Supplement: BIG MACS Diet
Dysbiosis, Sarcopenia, Colon Cancer
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University of Minnesota — Minneapolis, Minnesota Cyrus Jahansouz, MD

Multi-omics and Virtual Phenotyping in patients with Obesity: Multi-center Biobank and Outcomes Registry

Multi-center Biobank and Outcomes Registry for Obesity

Maria Hurtado Andrade
All
12 years and over
This study is NOT accepting healthy volunteers
2021-306361-H01-RST
21-011737
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Inclusion Criteria:

  • Patients 18 years or older with obesity (for adults BMI ≥ 30kg/m^2 or BMI ≥ 27kg/m^2 and at least one obesity-related chronic disease (such as type 2 diabetes mellitus, hypertension, obstructive sleep apnea, amongst others)).
  • Individuals undergoing an evaluation for weight loss interventions (e.g., diet, medication, bariatric endoscopic procedure, or surgery)


Exclusion Criteria:

  • Principal investigator discretion.
  • Individuals who are unable to sign consent (e.g., those declared legally incompetent).
  • Patients without a tracking device (smart phone or wearable device).

Eligibility last updated 5/3/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

KM3D Multicenter Cancer Consortium Study: Validation of In Vitro 3D Cell Culture Models for Tumor Drug Sensitivity After Tissue Removal (KM-20-001)

In Vitro 3D Cell Culture Models Validation for Tumor Drug Sensitivity after Tissue Removal

Janani Reisenauer
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306681-P01-RST
21-013027
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Inclusion Criteria:


- A demonstrated primary solid cancer for which it is medically indicated and planned to be surgically resected, biopsied, or drained (via malignant pleural effusion).

- The ability to ship the tissue sample within 24 hours of removal from the patient.

- Signed and dated consent to giving tissue as well as allowing for de-identified medical history information regarding administered treatments and treatment outcomes
to be shared.

- Over 18 years of age


Exclusion Criteria:


- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation in the opinion of the Investigator.

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Mayo Clinic — Rochester, MN

Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain (KALPAS)

Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain

William Hooten
Female
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-308362-P01-RST
22-005765
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Inclusion Criteria:


- Woman 18 years of age or older.

- Undergoing elective breast surgery for oncologic indication as follows: unilateral or bilateral mastectomy,  prophylactic-mastectomy, +/- lymph node dissection, +/- immediate or delayed reconstruction.

- No distant metastases.


Exclusion Criteria:


- History of cognitive impairment or clinical signs of altered mental status (AMS) that may interfere with adherence to study procedures and/or participant safety. Clinical signs of AMS may include but are not limited to: confusion, amnesia, disorientation, fluctuating levels of alertness, etc.

- Past ketamine or phencyclidine misuse or abuse.

- Schizophrenia or history of psychosis.

- History of post-traumatic stress disorder.

- Known sensitivity or allergy to ketamine.

- Liver or renal insufficiency.

- History of uncontrolled hypertension, chest pain, cardiac arrhythmia, stroke, head trauma, intracranial mass or hemorrhage, glaucoma, porphyria, uncontrolled thyroid disease, or other contraindication to ketamine.

- Lamotrigine, alfentanil, physostigmine, or 4-aminopyridine use.

- Currently pregnant.

- Body mass index (BMI) greater than 35.

- Non-English or non-Spanish speaker.

- Currently participating in another pain interventional trial.

- Unwilling to comply with all study procedures and be available for the duration of the study.

- Patient is American Society of Anesthesiologists (ASA) physical status 4, 5, or 6.

- Patient has started or undergone hormone therapy for gender transition into male.

- Patient scheduled for any bilateral (or greater) flap reconstruction.

Eligibility last updated 5/31/22. Questions regarding updates should be directed to the study team contact. 

Drug, Other
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A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer

Male
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05441501
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Inclusion Criteria:

• Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
• Measurable or evaluable disease
• At least 1 prior treatment for mCRPC
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ functions as defined by certain laboratory values
• Must sign an informed consent form (ICF)
• Participants must agree to use a highly effective form of birth control as guided by the study doctor
Exclusion Criteria:

• Concurrent anticancer therapy
• Severe or long-lasting side effects related to prior anticancer therapy
• Known allergies to JNJ-80038114 or its excipients
• Brain metastasis or known seizure history
• Significant infections or lung, heart or other medical conditions
Drug: JNJ-80038114
Prostatic Neoplasms
Prostate cancer
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University Of Minnesota — Minneapolis, Minnesota

MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum-Based Chemotherapy in Patients With Metastatic Urothelial Cancer (MAIN-CAV)

Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study

Daniel Childs
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2020-101973-P01-RST
22-010143
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Inclusion Criteria:


- Histologically or cytologically-confirmed diagnosis of advanced or metastatic
urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell
and mixed transitional/non-transitional cell histologies except for small-cell
histology), including N3 only disease prior to start of first-line platinum-based
chemotherapy.

- Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy
(platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin,
methotrexate, vinblastine, doxorubicin and cisplatin [MVAC] or dose-dense [dd]MVAC).

- No more than 1 line of prior chemotherapy for metastatic or locally advanced disease
(neoadjuvant or adjuvant chemotherapy will be allowed if given 12 or more months prior
to registration).

- Tumor objective response of CR, PR, or SD upon completion of first line platinum-based
chemotherapy by treating physician's assessment.

- The last dose of first-line chemotherapy must have been received no less than 3 weeks,
and no more than 10 weeks, prior to randomization in the present study.

- No prior immunotherapy with IL-2, IFN-alpha, or an anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug
specifically targeting T-cell co-stimulation or immune checkpoint pathways.

- Age ≥ 18 years.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Not pregnant and not nursing, because this study involves an agent that has known
genotoxic, mutagenic and teratogenic effects.

- Women of childbearing potential must have a negative pregnancy test ≤ 14 days prior
to registration.

- Women of childbearing potential include women who have experienced menarche and
who have not undergone successful surgical sterilization (hysterectomy, bilateral
tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post
menopause is defined as amenorrhea ≥ 12 consecutive months.

Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing
potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens,
ovarian suppression or any other reversible reason.

- No use of immunosuppressive medication within 7 days prior to randomization except:

- Intranasal, inhaled, topical steroids, or local steroid injections (e.g.,
intra-articular injection);

- Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or
equivalent;

- Steroids as premedication for hypersensitivity reactions (e.g., computed
tomography [CT] scan premedication).

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial.

- Patients with diabetes type I, vitiligo, psoriasis, or hypo or hyperthyroid disease
not requiring immunosuppressive treatment are eligible.

- Absolute neutrophil count (ANC) ≥ 1,000/mm^3.

- Platelet count ≥ 100,000/mm^3.

- Hemoglobin ≥ 8 g/dL.

- Calculated (Calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault
equation: (140
•age) × weight (kg)/(serum creatinine [mg/dL] × 72).

- Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN).

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (or ≤ 5
x ULN for patients with liver metastases or Gilbert's disease).

- Urine protein creatinine (UPC) ratio ≤ 1 or 24-hour protein < 1 g.


Exclusion Criteria:


- Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agent.

- No known symptomatic central nervous system (CNS) metastases. Patients with previously diagnosed CNS metastases are eligible if they have completed their treatment and have
recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued corticosteroid treatment for at least 2 weeks, and are neurologically stable. Baseline brain imaging with contrast-enhanced CT or magnetic resonance imaging (MRI) scans for subjects with known brain metastases is required to confirm eligibility.

- No major surgery within 4 weeks prior to randomization. Subjects must have complete
wound healing from surgery before randomization. Subjects with clinically relevant
ongoing complications from prior surgery are not eligible.

- No palliative radiotherapy within 48 hours prior to patient randomization.

- No hemoptysis of ≥ 0.5 teaspoon (2.5 mL) of red blood, clinically significant
hematuria, hematemesis, coagulopathy, or other history of significant bleeding (e.g.,
pulmonary hemorrhage) within 3 months before randomization.

- No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation.

- No administration of a live, attenuated vaccine within 30 days prior to randomization.
The use of inactivated (killed) vaccines for the prevention of infectious disease is
permitted. The use of COVID-19 vaccines is permitted.

- No uncontrolled, significant intercurrent or recent illness including, but not limited
to, the following conditions:

- Cardiovascular disorders including:

- Congestive heart failure (CHF): New York Heart Association (NYHA) class III
(moderate) or class IV (severe) at the time of screening;

- Concurrent uncontrolled hypertension defined as sustained blood pressure
(BP) > 150 mm Hg systolic, or > 90 mm Hg diastolic despite optimal
antihypertensive treatment;

- The patient has a known history of corrected QT interval calculated by the
Fridericia formula (QTcF) > 500 ms and confirmed by electrocardiogram (ECG)
within 28 days before randomization.

Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3
minutes should be performed. If the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard;

- Any history of congenital long QT syndrome;

- Stroke, transient ischemic attack (TIA), myocardial infarction, or other
symptomatic ischemic event or thromboembolic event (e.g., deep venous
thrombosis, pulmonary embolism (DVT/PE) within 6 months before
randomization. Subjects with a diagnosis of incidental, subsegmental PE or
DVT within 6 months are allowed if asymptomatic and stable at screening and
treated with low molecular weight heparin (LMWH) or the direct factor Xa
inhibitors rivaroxaban, edoxaban, or apixaban for at least 1 week before
randomization. Non-symptomatic white matter disease in the brain is
acceptable;

- No significant gastrointestinal disorders, particularly those associated with a
high risk of perforation or fistula formation including unresolved active peptic
ulcer disease, cholecystitis, diverticulitis, symptomatic cholangitis or
appendicitis, or malabsorption syndrome within 28 days of randomization.

- No other clinically significant disorders such as:

- Any active infection requiring systemic treatment within 14 days before
randomization. Subjects receiving oral (including prophylactic) antibiotics
with no symptoms of infection at randomization are eligible;

- Serious non-healing wound/ulcer/bone fracture within 28 days before
randomization;

- History of organ or allogeneic stem cell transplant;

- No persisting toxicity related to prior therapy grade > 2 constituting a safety
risk based on the investigator's judgment;

- No diagnosis of any other malignancy within 3 years prior to randomization,
except for locally curable cancers that have been adequately treated such as
basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of
the cervix, Gleason < 7 prostate cancer on surveillance without any plans for
treatment intervention (e.g., surgery, radiation, or castration), or prostate
cancer that has been adequately treated with prostatectomy or radiotherapy and
currently with no evidence of disease or symptoms and no indication for treatment;

- No concomitant anticoagulation with coumarin agents (e.g., warfarin), direct
thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or
platelet inhibitors (e.g., clopidogrel).

- Allowed anticoagulants are the following:

- Prophylactic use of low-dose aspirin for cardio-protection (per local
applicable guidelines) and low-dose low molecular weight heparins
(LMWH).Therapeutic doses of LMWH or anticoagulation with direct factor
Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without
known brain metastases who are on a stable dose of the anticoagulant
for at least 1 week before first dose of study treatment without clinically
significant hemorrhagic complications from the anticoagulation regimen or the tumor.

- Physicians should consider whether any of the following may render the patient
inappropriate for this protocol:

- Psychiatric illness which would prevent the patient from giving informed consent;

- Uncontrolled medical conditions which, in the opinion of the treating physician,
would make this protocol unreasonably hazardous for the patient;

- Patients who cannot swallow oral formulations of the agent(s).

In addition:

- Women and men of reproductive potential should agree to use an appropriate method of
birth control throughout their participation in this study due to the teratogenic
potential of the therapy utilized in this trial. Include as applicable: Appropriate
methods of birth control include abstinence, oral contraceptives, implantable hormonal
contraceptives or double barrier method (diaphragm plus condom);

- Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjogren's
syndrome and psoriasis controlled with topical medication and or steroids equivalent
to < 10 mg prednisone daily, not on immunosuppressive medications and patients with
positive serology are eligible. Patients with vitiligo, endocrine deficiencies including
hypo or hyper thyroid disease managed with replacement, diabetes type 1 are
eligible.

- Sexually active subjects (men and women) must agree to use medically accepted barrier
methods of contraception (e.g., male or female condom) during the study and continue
for 4 months after the last dose of study drugs, even if oral contraceptives are also
used.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/22/22. Questions regarding updates should be directed to the study team contact.

Drug, Other
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