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Pelvic Health Electrically Evoked Recording (PEER) 2 Study (PEER2)

Recording Pelvic Health Signals After Stimulation of a Sacral Nerve

Brian Linder
All
18 years and over
Not Applicable, Feasibility
This study is NOT accepting healthy volunteers
2021-306315-P01-RST
21-011168
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Inclusion Criteria
•Overactive Bladder:

  • 18 years of age or older.
  • Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation.
  • Willing and able to provide signed and dated informed consent.
  • Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
  • Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation.
  • For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstrated on a voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion).
  • For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary with greater than or equal to 8 urgency frequency episodes per day.
  • *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Inclusion Criteria
•Non-Obstructive Urinary Retention:

  • 18 years of age or older.
  • Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation.
  • Willing and able to provide signed and dated informed consent..
  • Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
  • Willing to maintain current regimen (dosage and frequency) of any NOUR medication from baseline diary through the end of therapy evaluation.
  • Have a diagnosis of non-obstructive urinary retention as demonstrated by a urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations in a 7-day period; and chronic non-obstructive urinary. retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.
  • *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Inclusion Criteria - Fecal Incontinence:

  • 18 years of age or older.
  • Candidate for or undergoing Medtronic InterStim lead implant labeled indication* requiring an advanced evaluation.
  • Willing and able to provide signed and dated informed consent.
  • Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
  • Willing to maintain current regimen (dosage and frequency) of any FI medication from baseline diary through the end of therapy evaluation.
  • Have a diagnosis of fecal incontinence as demonstrated by a bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate, or severe soiling) per week.
  • *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Exclusion Criteria
•Overactive Bladder:

  • Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
  • Implanted with a neurostimulator, pacemaker or defibrillator.
  • Pelvic floor muscle dysfunction due to surgical intervention or injury.
  • Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
  • History of diabetes unless the diabetes is well‐controlled through diet and/or medications.
  • Have symptomatic urinary tract infection (UTI).
  • Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component.
  • Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study.
  • Treatment of symptoms with tibial neuromodulation therapy in the last 3 months.
  • Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study.
  • Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy.
  • Women who are pregnant or planning to become pregnant.
  • Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
  • Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Exclusion Criteria - Non-Obstructive Urinary Retention:

  • Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
  • Implanted with a neurostimulator, pacemaker or defibrillator.
  • Pelvic floor muscle dysfunction due to surgical intervention or injury.
  • Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
  • History of diabetes unless the diabetes is well‐controlled through diet and/or medications
  • Have symptomatic urinary tract infection (UTI)
  • Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
  • Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
  • Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
  • Women who are pregnant or planning to become pregnant
  • Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
  • Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Exclusion Criteria
•Fecal Incontinence:

  • Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
  • Implanted with a neurostimulator, pacemaker or defibrillator.
  • Pelvic floor muscle dysfunction due to surgical intervention or injury.
  • Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
  • Have uncorrected high grade internal rectal prolapse.
  • Treatment of symptoms with tibial neuromodulation therapy in the last 3 months.
  • Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study.
  • Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy.
  • Women who are pregnant or planning to become pregnant.
  • Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Eligibility last updated 10/22/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Natural History Study for DNA Repair Disorders

All
6 Months and over
This study is NOT accepting healthy volunteers
NCT05484570
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Inclusion Criteria:

• Diagnosis of Cockayne syndrome (CS), xeroderma pigmentosum (XP), or trichothiodystrophy (TTD), based on genetic testing and/or key clinical characteristics l characteristics
• Has one or more of the following neurodevelopmental or neurological complications
• Gross motor delay (non-ambulatory or started walking after age 18 months)
• Language delay (non-verbal or started talking after 18 months)
• Altered muscle tone (hypertonia, dystonia, hypotonia)
• Gait difficulties, including stiff gait, short stride, frequent falls, use of orthotics, use of walker
• Tremors
• Microcephaly
• Is a family member of an individual with the above condition
• No restrictions regarding current ambulatory status
• Minimum age for enrollment eligibility will be 6 months due to fragility of neonates with severe forms of DNA repair disorders and limitations of motor assessment scales in infants younger than 6 months. There will be no maximum age for enrollment eligibility.
• No restrictions regarding gender, race, or ethnicity.
• Voluntary written consent from the participant if adult capable of consenting or parent/guardian if minor or not capable of consenting
• Written consent of Legally Authorized Representative if enrolling adult lacks capacity to consent
Exclusion Criteria:

• Any prior history of systemic gene or cell-based therapy
• Current participation in an interventional clinical trial
Other: Interval History, Other: Physical Examination, Other: ECAB Assessment, Other: Gait Assessment, Other: Specimen Sample Collection
DNA Repair Disorder, Cockayne Syndrome, Xeroderma Pigmentosum, Trichothiodystrophy
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University of Minnesota- Twin Cities — Minneapolis, Minnesota Peter Kang, MD - (pkang@umn.edu) Natalya Alassy, MBS - (burla019@umn.edu)

PV Loop and Pulmonary Hypertension

All
1 Year to 18 Years old
This study is NOT accepting healthy volunteers
NCT05484596
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Inclusion Criteria:

• Children 1-18 years of age
• Patients referred for cardiac catheterization for hemodynamic evaluation due to concern for pulmonary hypertension
• Structurally normal heart
Exclusion Criteria:

• Pulmonary hypertension secondary to pulmonary venous hypertension defined as pulmonary capillary wedge pressure of more than or equal to 15mmHg
• Pulmonary hypertension secondary to mixed pulmonary arterial and venous hypertension
• Patient will be excluded from performing an MRI if they have: claustrophobia, metal implants or allergy to contrast
• Patients will be excluded from performing a cardiopulmonary exercise test (CPET) if they are: 1) less than 8 years or 2) unable to follow instructions to run on a treadmill.
Procedure: Measuring VA Coupling
Pulmonary Vascular Resistance Abnormality
pulmonary vascular resistance, pediatric, VA uncoupling
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University of Minnesota — Minneapolis, Minnesota Brittany Faanes, MPH, CCRP - (grego318@umn.edu)

Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity

All
12 Years to 20 Years old
Early Phase 1
This study is NOT accepting healthy volunteers
NCT04881799
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Inclusion Criteria:

• Ages 12 to • Obesity (BMI >/= the 95th percentile for age and sex)
• HgbA1c >/= 6.5% at type 2 diabetes diagnosis
• Negative diabetes auto-antibodies
• English-speaking
• For participants of child-bearing potential: when sexually active, agreement to use two forms of highly effective contraception (oral contraceptive pill, IUD, implant, and/or condoms) during study participation
Exclusion Criteria:

• Pregnancy or lactation
• Newly-initiated or change in dose of weight altering medication within past 6 months, including SGLT-2 inhibitors and DPP-IV inhibitors
• Current or recent (< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination PHN/TPM, liraglutide, semaglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
• Current use of sulfonylureas
• Previous metabolic/bariatric surgery
• Current use of a stimulant medication
• History of glaucoma
• Current or recent (< 14 days) use of monoamine oxidase inhibitor or carbonic anhydrase inhibitors
• Known hypersensitivity to sympathomimetic amines
• Any history of treatment with growth hormone
• any history of bulimia nervosa
• Major psychiatric disorder as determined by the local medical monitor
• Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression or PHQ-9 score of >/= 15
• Any history of active suicide attempt, a "yes" answer to Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) on the "Suicidal Ideation" portion of the C-SSR, or a "yes" to answer to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS
• History of suicidal ideation or self-harm within the previous 30 days or a "yes" answer to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) on the "Suicidal Behavior" portion of the C-SSRS and the ideation or behavior occurred within the past month.
• Current pregnancy or plans to become pregnant during study participation
• Current tobacco use
• ALT or AST >/= 3 times the upper limit of normal
• Moderate (Child-Pugh score 7-9) or severe (Child-Pugh score 10-15)
• Bicarbonate <18 mmol/L
• Moderate (creatinine clearance [CrCl] greater than or equal to 30 and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment
• Any history of seizures • BP for ages 13 and older of > 130/80 on 3 separate measurements and for age 12 > 95th percentile on 3 separate measurements
• HR ≥120 bpm on 3 separate measurements
• History of structural heart defect or clinically significant arrhythmia
• Diagnosed monogenic obesity
• Any history of cholelithiasis
• Any history of nephrolithiasis
• Clinically diagnosed hyperthyroidism
• Untreated thyroid disorder or TSH below the lower laboratory limit of normal
• Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion may put the participant at risk
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Safety and Feasibility of Kefir Administration in Critically Ill Adults

Safety and Feasibility of Kefir Administration in Critically Ill Adults

Lioudmila Karnatovskaia
All
18 years and over
ERROR
This study is NOT accepting healthy volunteers
2020-300928-H01-RST
20-005687
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Inclusion Criteria:

  • Critically ill adult (>18 years old) patients and expected to have >48-hour ICU stay.
  • Functional GI tract (able to tolerate oral diet or tube feeding).


Exclusion Criteria:

  • Premorbid known immunosuppression over 1 month duration (due to medications including chronic steroids, TNF-alpha inhibitors, monoclonal antibodies, immunosuppressive antimetabolites, etc.).
  • Compromised gut integrity (bowel resection, GI malignancy, GI bleed, inflammatory bowel disease, intestinal obstruction, intra-abdominal hypertension, intestinal ischemia/reperfusion injury or secondary ileus).
  • Dairy intolerance or milk allergy.
  • Extremely poor prognosis and not expected to survive the treatment period.
  • Goals of care change to comfort care.
  • Pregnant patients.
Dietary Supplement
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Mayo Clinic — Rochester, MN

Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study) (MAGNETIC Study)

Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

Zhaohui Jin
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307312-P01-RST
22-001698
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Inclusion Criteria:

  • Male or female and ≥ 18 years-of-age at the time of informed consent.
  • ECOG Performance status 0 or 1.
  • Locally advanced or metastatic resistant or refractory solid tumors.
  • Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible.
  • Measurable disease as per RECIST v1.1.
  • Ability to swallow and retain oral medications.
  • Acceptable hematologic and organ function at screening.
  • Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.
  • Resolution of all toxicities of prior therapy or surgical procedures.
  • Life expectancy ≥ 12 weeks after the start of the treatment.


Exclusion Criteria:

  • Chemotherapy or small molecule antineoplastic agent given within 21 days or < 5 half- lives, whichever is shorter, prior to first dose of study drug.
  • History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Known sensitivity to any of the ingredients of RP-6306 or gemcitabine.
  • Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
  • Major surgery within 4 weeks prior to first dose of RP-6306 and gemcitabine.
  • Uncontrolled, symptomatic brain metastases.
  • Uncontrolled hypertension.
  • Moderate or severe hepatic impairment.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

A Phase 0/Ia Study of BI 907828 Concentrations in Brain Tissue and a Non-randomized Open-label, Dose- escalation Study of BI 907828 in Combination with Radiotherapy in Patients with Newly-diagnosed Glioblastoma (BI 1403-0007)

A Study to Determine How BI 907828 is Taken up in the Tumor and to Determine the Highest Dose of BI 907828 That Could be Tolerated in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma

Jann Sarkaria
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307429-P01-RST
22-002233
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Inclusion Criteria
•Main Phase 0:

  • Histologically (if prior biopsy) or radiologically diagnosed glioblastoma.
  • Neurosurgical tumor resection is indicated and planned, according to the assessment of the treating physician.
  • Patients must be at least 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate organ function.
  • Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.

Inclusion Criteria
•Main Phase Ia:

  • Histologically demonstrated diagnosis of TP53 wild type glioblastoma harboring unmethylated MGMT promoters (Glioblastoma definition according to 2021 WHO Classification of CNS tumors; i.e., IDH-wild type only).
  • Patient has undergone neurosurgical tumor resection and is eligible for standard radiotherapy.
  • Formalin-fixed paraffin-embedded tumor blocks or representative H/E (haematoxylin/eosin) slides (preferably both) must be available for retrospective histopathological central review. Locally performed histopathological diagnosis will be accepted for entry into this trial.
  • Patients must be at least 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate organ function.
  • Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.

Exclusion Criteria
•Main Phase 0:

  • Known TP53 mutant glioblastoma (Note: testing is not mandatory for inclusion).
  • Known IDH mutant grade IV astrocytoma.
    • Note: testing is not mandatory for inclusion.
  • Patients with pacemakers or other metallic implants that can interfere with the magnetic field during MRI investigations.
  • Inability to undergo contrast-enhanced MRI (GFR < 30 mL/min).

Exclusion Criteria
•Main Phase Ia
:

  • Patients who have received previous systemic therapy (with the exception of patients who participated in Phase 0) or radiotherapy for glioblastoma.
  • Patients with pacemakers or other metallic implants that can interfere with the magnetic field during MRI investigations.
  • Inability to undergo contrast-enhanced MRI (GFR < 30 mL/min).

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

Eligibility last updated 12/26/23. Questions regarding updates should be directed to the study team contact

Drug, Radiation
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Mayo Clinic — Rochester, MN

Colorectal Cancer Screening in Cystic Fibrosis (NICE-CF)

All
18 Years to 75 Years old
This study is NOT accepting healthy volunteers
NCT05362344
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Inclusion Criteria:
1. Adults with CF ages 18
•75 years and due for a routine screening or surveillance colonoscopy for colon cancer 2. Cystic Fibrosis diagnosis, defined by a sweat chloride test result ≥ 60 mmol/L (may be of historic value), and/or documented CF-causing CFTR mutations and clinical features of CF 3. Capable of understanding the purposes and risks of the study in English or Spanish and willing to participate and sign informed consent 4. Referred for screening or surveillance colonoscopy for CRC (current standard of care) and willing to undergo colonoscopy and stool testing 5. Able to access the Internet to complete self-administered surveys
Exclusion Criteria:
1. Any condition that, in the opinion of the site PI, introduces undue risk by participating in this study 2. Incapable of understanding the purposes of the study or informed consent for any reason 3. Pregnancy 4. Active inflammatory bowel disease as defined by a prior diagnosis of Crohn's Disease or Ulcerative Colitis, based on both clinical and histopathologic findings and the individual currently on medical therapy for Crohn's disease or Ulcerative Colitis. 5. Personal history of colon cancer diagnosis and treatment within 5 years of enrollment 6. Symptoms that merit colonoscopy for diagnostic purposes rather than as screening for CRC 7. Known history of familial colon cancer syndrome that has been confirmed by previous genetic testing
Procedure: Stool tests
Cystic Fibrosis, Colorectal Cancer, Adenoma
Cystic Fibrosis, Colorectal Cancer, Cancer screening, Adenoma
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University of Minnesota — Minneapolis, Minnesota Melissa Rhodes, RN - (frak0001@umn.edu) Mary Bailey, RRT - (mpbailey@umn.edu)

LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients with an Advanced Solid Tumor (LuMIERE)

A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)

Ajit Goenka
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-305200-P01-RST
21-007085
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Inclusion Criteria:


- Be ≥ 18 years of age at the time the ICF is signed.

- Consent to submission of archival tumor tissue, if available.

- Adequate bone marrow, hepatic, and renal function.

- ECOG performance status of 0 or 1.

- Life expectancy of at least 6 months.

- Measurable disease per RECIST v1.1.

Phase 1 only:

? Patients must have an advanced/metastatic solid tumor that is refractory to or has
progressed following prior treatment and has no satisfactory alternative treatment options.

Patient enrolled in Phase 2 will have one of several specific tumor types with advanced or
recurrent or metastatic disease following prior therapy.


Exclusion Criteria:


- Active second malignancy that may interfere with the safety or efficacy assessments of
this study

- Symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal
disease or with primary tumor of CNS origin. Patients must be clinically stable for at
least 4 weeks without steroid treatment

- Received anticancer treatment ≤ 14 days prior to receiving study treatment (≤ 28 days
prior in case of checkpoint inhibitor or other antibody therapies)

- Received prior radiopharmaceutical therapy or radioembolization, or prior extensive
external beam radiation therapy (EBRT) to bone marrow or any prior EBRT to kidney, or
received any EBRT within 2 weeks prior to administration of study treatment

- Ongoing adverse effects from anticancer treatment > Grade 1, with the exception of
alopecia

- Known incompatibility with contrast media for CT or PET scans. Infection requiring
systemic antibiotics within 2 weeks prior to administration of study treatment

- Impaired cardiac function or clinically significant cardiac disease

- Severe urinary incontinence, voiding dysfunction, or urinary obstruction

- Minor surgery ≤ 5 days, or major surgery ≤ 21 days, prior to administration of study
treatment.

- Any other condition that may increase the risk associated with study participation or
interfere with its interpretation.

- Refusal to use highly effective method of contraception, as applicable

- Pregnant or breastfeeding

- Any other condition that may increase the risk associated with study participation or
interfere with its interpretation.

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

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)

Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)

Cadman Leggett
All
45 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307142-P01-RST
22-001278
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Inclusion Criteria:
 

  • Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥ years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
  • Between the ages of 45 and 80 years, inclusive.
  • Able and willing to provide written informed consent.


Exclusion Criteria:

  • Self-reported pregnancy.
  • Known diagnosis of Colorectal Cancer.
  • History of, or referral for, Inflammatory Bowel Disease.
  • Previous surgery involving the colon or rectum.
  • Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
  • High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.
  • Referral for overt, symptomatic gastrointestinal bleeding.

Eligibility last updated 2/4/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

TVMR With the Innovalve System Trial - Early Feasibility Study (TWIST-EFS) (TWIST-EFS)

TVMR With the Innovalve System Trial - Early Feasibility Study

Charanjit Rihal
All
18 years and over
Phase 1, First In Human
This study is NOT accepting healthy volunteers
2021-304606-P01-RST
21-004739
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Inclusion Criteria:


- Clinically significant, symptomatic mitral regurgitation.

- High risk for open-heart surgery.

- Meets anatomical criteria.


Exclusion Criteria:


- Unsuitable anatomy.

- Patient is inoperable.

- EF< 30%.

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

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

(ECTx) A Phase 1 Study of ERK1/2 Inhibitor JSI-1187 Administered as Monotherapy and in Combination With Dabrafenib for the Treatment of Advanced Solid Tumors With MAPK Pathway Mutations

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations

Robert McWilliams
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307388-P01-RST
22-002123
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Inclusion Criteria:

  • Males and females ≥ 18 years of age
  • Have locally advanced or metastatic solid tumor malignancy with measurable disease and be an appropriate candidate for experimental therapy.
  • Part A (JSI-1187 Monotherapy Dose Escalation):
    • Histologically or cytologically confirmed MAPK pathway mutation, including hyperactivating pathway mutations or gene fusions; e.g., BRAF (Class I, II or III), RAS (H/K/N), MEK (MAP2K1), RAS-GAP (NF1 loss, RASA1), RAS-GEF, refractory to or relapsed on prior therapy, and have received all available therapy known to confer clinical benefit.
    • Part B (JSI-1187 Plus Dabrafenib Combination Dose Escalation):
      • Histologically or cytologically confirmed BRAF V600-mutated locally advanced or metastatic solid tumor, refractory to, or relapsed on, prior therapy, and have received all available therapy known to confer clinical benefit.
  • Part C (JSI-1187 Plus Dabrafenib Expansion Cohorts): Histologically or cytologically confirmed:
    • Cohort 1: BRAF V600-mutated metastatic melanoma after two prior therapies for metastatic disease, including anti-PD1 therapy, with or without ipilimumab, and BRAF/MEK inhibitor treatment;
    • Cohort 2: BRAF V600-mutated metastatic melanoma after adjuvant therapy for Stage 3 disease followed by one prior therapy for metastatic disease, including anti-PD-1 therapy, with or without ipilimumab or BRAF/MEK inhibitor treatment;
    • Cohort 3: Either BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC), or BRAF V600-mutated metastatic solid tumor, after 1 or 2 prior therapies.
  • MAPK mutation tumor status will be established prior to entry based on previous MAPK pathway mutation reports from a CLIA qualified laboratory, or, if a report is not available, the mutation analysis will be performed at Screening on archival tissue or newly biopsied tumor tissue.
  • Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ≤ 1.
  • Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2.
  • Life expectancy of ≥ 3 months -Subjects with asymptomatic stable, prior or currently treated brain metastases are allowed -Adequate hematologic parameters without ongoing transfusional support:
    • Hemoglobin (Hb) ≥ 9 g/dL -Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 cells/L;
    • Platelets ≥ 75 x 10^9 cells/L -Adequate renal and hepatic function;
    • Creatinine ≤ 1.5 times the upper limit of normal (ULN), or calculated creatinine clearance ≥ 50 mL/minute x 1.73 m^2 per the Cockcroft-Gault formula;
    • Total bilirubin ≤ 2 times the (ULN) unless due to Gilbert's disease;
    • ALT/AST ≤ 2.5 times the ULN, or < 5 times the ULN for subjects with liver metastases.
  • Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy throughout the study and for 28 days after the completion of study treatment.
  • Ability to provide written informed consent.
  • Current allowed disease states:

• BRAF V600E/K-mutated unresectable or metastatic melanoma;
• BRAF V600E-mutated metastatic NSCLC;
• BRAF V600E-mutated locally advanced or metastatic anaplastic thyroid cancer;
• Other BRAF V600E-mutated unresectable or metastatic solid tumors, excluding colorectal cancer.

  • Revised allowed disease states with March 2023 dabrafenib + trametinib U.S. product approval:

• BRAF V600E/K-mutated unresectable or metastatic melanoma;
• BRAF V600E-mutated metastatic NSCLC;
• BRAF V600E-mutated locally advanced or metastatic anaplastic thyroid cancer;
• Other BRAF V600E-mutated unresectable or metastatic solid tumors who have progressed following prior treatment and have no satisfactory alternative treatment options.


Exclusion Criteria:

  • Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV.
  • QT interval corrected for rate (QTc) > 480 msec on the ECG obtained at Screening using Fridericia method for QTc calculation.
  • Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.
  • Medications that are strong inhibitors of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
  • Medications that are strong inducers of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
  • Medications that are strong inhibitors of BCRP are prohibited during study and for 14 days prior to the first dose of study drugs(s).
  • Subjects on dabrafenib (Parts B and C) also are advised to avoid concurrent administration of strong inhibitors of CYP2C8 as these medications may increase the concentration of dabrafenib -History of or current evidence/risk of retinal vein occlusion or central serous retinopathy, or has medically relevant abnormalities identified on screening ophthalmologic examination -Symptomatic central nervous system malignancy or metastasis -Gastrointestinal conditions that could impair absorption of study drug(s).
  • Current hematologic malignancies -Second, active primary solid tumor malignancy that, in the judgement of the investigator or Sponsor medical monitor, may affect the interpretation of results.
  • Prior malignancies, with the exception of carcinoma in situ of any origin, non-muscle invasive bladder cancer, Gleason 3+3 prostate cancer and prior malignancies in remission whose likelihood of recurrence is very low, as judged by the Sponsor medical monitor.
  • Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment within the last week prior to study treatment.
  • Other active infection requiring IV antibiotic usage within the last week prior to study treatment.
  • Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.
  • Participation within the last 28 days in a clinical trial, or currently enrolled in a clinical trial, involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Previously completed or withdrawn from this study or any other study investigating an ERK1/2 inhibitor.
  • If female, pregnant, breast-feeding, or planning to become pregnant.

Eligibility last updated 6/1/23. Questions regarding updates should be directed to the study team contact.

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Initial Correction Keratoconus: Scleral vs. Corneal Gas Permeable Lenses (SVGPL)

SCOPE Study

Muriel Schornack
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305925-P01-RST
21-009776
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Inclusion Criteria:

  • Age 18 or older.
  • Diagnosis of keratoconus.
  • Available baseline corneal topography and pachymetry.
  • Amsler-Krumeich keratoconus classification of stage 1 or higher.


Exclusion Criteria:

  • No prior corneal transplantation or INTACTS.
  • No prior use of hybrid, corneal or scleral gas permeable lenses.
  • Presence of corneal scarring.

Eligibility last updated 9/17/21. Questions regarding updates should be directed to the study team contact.

 

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A Phase I Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination With Pembrolizumab in Patients With Platinum Resistant or Refractory Ovarian Cancer (PROTA)

A Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) Combined with Pembrolizumab to Treat Refractory Ovarian Cancer

Matthew Block
Female
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306701-P01-RST
22-000078
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Inclusion Criteria:


- Signed and dated informed consent(s) by the participant or legal representative before
any trial-related activities.

- Female over 18 years of age on day of signing informed consent(s).

- Histologically confirmed ovarian cancer (including fallopian tube and primary
peritoneal cancer) resistant to platinum (defined as progression of cancer within 183
days of the most recent dose of cisplatin or carboplatin) or refractory to platinum
(defined as progression of cancer within 30 days of the most recent dose of cisplatin
or carboplatin) ovarian cancer, which cannot be treated with curative intent with
available therapies. Note: Poly(ADP)-ribose polymerase (PARP) inhibitors should be
considered as indicated in clinical practice, prior to trial enrollment.

- At least one tumor (>14 mm in diameter) or carcinomatosis must be available for local
virus injection (intratumoral and/or intraperitoneal).

- The disease burden must be evaluable, but does not need to fulfil RECIST 1.1.

- Have adequate organ function as defined in the following values below. Specimens must
be collected within 10 days prior to the start of study treatment.

a. Hematological laboratory values i. Absolute neutrophil count (ANC): ≥1500/µL ii.
Platelets: ≥ 100 000/µL iii. Hemoglobin: ≥9.0 g/dL or ≥5.6 mmol/L. Criteria must be
met without packed red blood cell (pRBC) transfusion within the prior 2 weeks.
Participants can be on stable dose of erythropoietin (≥ approximately 3 months. iv.
Leukocytes (WBC) > 3.0 b. Renal laboratory values i. Glomerular Filtration Rate (GFR):
>60 ml/min (Cockcroft-Gault formula). c. Hepatic laboratory values i. Total bilirubin:
≤1.5 × Upper Limit of Normal (ULN) OR direct bilirubin ≤ULN for participants with
total bilirubin levels >1.5 × ULN (excluding patients with Gilbert's Disease) ii.
Aspartate Aminotransferase (AST) (SGOT) and Alanine Aminotransferase (ALT) (SGPT):
≤2.5 × ULN (≤5 × ULN for participants with liver metastases)

- Patients must be willing to use adequate forms of contraception from screening, during
the trial, and for a minimum of 120 days after end of treatment, in accordance with
the following:

i. Women of childbearing potential: Barrier contraceptive method (i.e. condom) must be
used in addition to one of the following methods: Intrauterine devices or hormonal
contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings
or long-acting injections). ii. Women not of childbearing potential: Barrier
contraceptive method (i.e. condom) must be used.

- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
score of 0-1 at screening.

- Life expectancy longer than 3 months.

- Capable of understanding and complying with parameters as outlined in the protocol.


Exclusion Criteria:


- Has an active autoimmune disease that has required systemic treatment in past 2 years
(i.e., with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency) and inhaled and topical
treatments are not considered a form of systemic treatment and are allowed.

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study drug.

- Treated with any anti-cancer therapy within 30 days prior to the first virus
injection. Anti-cancer therapy is defined as anti-cancer agents (e.g. surgery,
chemotherapy, immune-checkpoint inhibitors, kinase inhibitors, PARP inhibitors,
biological therapies, hormonal therapies, radiation, etc.). Continuation of hormonal
therapy or use of bone modifying agents (e.g. bisphosphonate or denosumab) is allowed
if started at least 3 months before.

- Participants must have recovered from all Adverse Events (AE)s due to previous
therapies to ≤Grade 1or baseline. Participants with ≤Grade 2 neuropathy may be
eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or
hormone replacement may be eligible. If the participant had major surgery, the
participant must have recovered adequately from the procedure and/or any complications
from the surgery prior to starting study intervention.

- Treated with a prior radiotherapy, including for palliative purposes, within 2 weeks
of start of study treatment (before or after). Participants must have recovered from
all radiation-related toxicities, not require corticosteroids, and not have had
radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2
weeks of radiotherapy) to non-Central Nervous System (CNS) disease. Palliative
radiation is allowed from day 15 during the trial treatment period, if deemed
necessary by the investigator.

- Treated with a prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or
with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,
Cytotoxic T lymphocyte-associated Antigen (CTLA)-4, Tumor necrosis factor receptor
superfamily, member 4 (OX40), CD137), and was discontinued from that treatment due to
a Grade 3 or higher immune-related Adverse Events (irAE).

- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 30 days prior to the first virus
injection. An investigational agent is any drug or therapy that is currently not
approved for use in humans. Participants who have entered the follow-up phase of an
investigational study may participate as long as it has been 4 weeks after the last
dose of the previous investigational agent.

- Uncontrolled cardiac or vascular diseases.

- History of myocardial infarction or cerebral stroke within the previous 12 months
before screening or is not sufficiently recovered from an older infarction or cerebral
stroke.

- History of severe hepatic dysfunction.

- History of hepatitis B (defined as HBsAg reactive), Hepatitis C (defined as hepatitis
C virus (HCV) RNA [qualitative] is detected) and/or HIV. No testing for Hepatitis B,
Hepatitis C and HIV is required unless mandated by a local health authority.

- History of coagulation disorder.

- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the participant's
participation for the full duration of the study, or is not in the best interest of
the participant to participate, in the opinion of the treating investigator.

- Female patients who are pregnant, breastfeeding or intend to become pregnant. Women of
childbearing potential who has a positive urine pregnancy test (within 72 hours) prior
to treatment. If the urine test is positive or cannot be confirmed as negative, a
serum pregnancy test will be required.

- Has a known additional malignancy that is progressing or has required active treatment
within the past 5 years. Participants with basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical
cancer in situ) that have undergone potentially curative therapy are not excluded.

- Has known active CNS metastases and/or carcinomatous meningitis. Participants with
previously treated brain metastases may participate provided they are radiologically
stable, i.e., without evidence of progression for at least 3 months by repeat imaging
(note that the repeat imaging should be performed during study screening), clinically
stable and without requirement of steroid treatment for at least 14 days prior to
first dose of study treatment.

- Has an active infection requiring systemic therapy.

- Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.

- Has a known psychiatric or substance abuse disorder that would interfere with the
participant's ability to cooperate with the requirements of the study.

- Allergy to ingredients present in the investigational medicinal products (ingredients
are listed in the protocol) ie. severe hypersensitivity (≥Grade 3) to pembrolizumab
and/or any of its excipients.

- Known contraindications to pembrolizumab.

- Has had an allogenic tissue/solid organ transplant.

- Has received a live or live-attenuated vaccine within 30 days prior to the first dose
of study intervention. Administration of killed vaccines are allowed.

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

Eligibility last updated 3/14/23. Questions regarding updates should be directed to the study team contact.

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A Post-market Study for Continuing Evaluation and Periodic Reporting of the Safety and Effectiveness of the Spatz3 Intragastric Balloon (PAS-S)

Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

Barham Abu Dayyeh
All
22 years to 65 years old
Post Market
This study is NOT accepting healthy volunteers
2022-307203-P01-RST
22-001232
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Inclusion Criteria:

  • Age 22
    •65 years.
  • BMI ≥ 35 and < 40 kg/m^2 or BMI of 30 to 34.9 kg/m^2 with one or more major obesity-related comorbid conditions.
  • Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
  • History of obesity (BMI ≥ 30) for at least 2 years.
  • History of failure with non-surgical weight loss methods.
  • Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling.
  • Residing within a reasonable distance from the investigator’s office and able to travel to the investigator to complete all routine follow-up visits.
  • Ability to give informed consent.
  • Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.  Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence.  Should a treatment arm subject become pregnant during the implantation period, the balloon will be extracted during the second trimester
    •the timing of which will be determined via consultation with the subject’s obstetrician.


Exclusion Criteria:

  • Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery.
  • Prior open or laparoscopic bariatric surgery.
  • Prior surgery of any kind on the esophagus, stomach, duodenum or any type of hiatal hernia surgery.
  • Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett’s esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease
  • Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
  • A gastric mass.
  • A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms.
  • Acid reflux symptoms to any degree that require more than one medication for symptom control.
  • A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
  • Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device.
  • Severe coagulopathy.
  • Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
  • Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
  • Chronic abdominal pain.
  • Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation.
  • Hepatic insufficiency or cirrhosis.
  • Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months.
  • Alcoholism or drug addiction.
  • Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
  • Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
  • Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
  • Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
  • Patients who have BOTH:
    • A previous history of a serotonin syndrome; AND
    • currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)].
  • Patients who are pregnant or breast-feeding.
  • Subjects with severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs.
  • Subjects who have tested positive for H. Pylori, and who have not yet been treated.

Eligibility last updated 2/3/22. Questions regarding updates should be directed to the study team contact.

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MC200807, Phase 1/2 Trial of Iberdomide in Combination with Daratumumab, Bortezomib, and Dexamethasone in Patients with Newly-diagnosed Multiple Myeloma (IDEAL) (IDEAL)

Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study

Prashant Kapoor
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2020-302443-P01-RST
21-006604
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Inclusion Criteria:


- Age >= 18 years at the time of signing the informed consent form (ICF).

- Previously untreated multiple myeloma or have received no more than one cycle of any anti-myeloma treatment regimen.

- NOTE: Prior radiation therapy for the treatment of solitary plasmacytoma is permitted. Prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate or zoledronic acid is permitted. Any additional agents not
listed must be approved by the principal investigator.

- Measurable disease:

  • Serum M-protein ≥ 0.5 g/dL;
  • Urine M-protein ≥2 00 mg in a 24-hour collection;
  • Serum Free Light Chain level ≥ 10 mg/dL provided the free light chain ratio is abnormal;
  • Measurable plasmacytoma (at least one lesion that has a single diameter of ≥ 2 cm on PET-CT scan);
  • Bone marrow plasma cells ≥ 30%
  • Patients with IgA myeloma in whom serum protein electrophoresis is deemed unreliable, due to co-migration of normal serum proteins with the para protein in the beta region, may be considered eligible as long as total serum IgA level is elevated above normal range;
  • For patients with EMD measurable disease by CT or MRI or the CT portion of the PET/CT: Must have at least one lesion that has a single diameter of ≥ 2 cm. Skin lesions can be used if the area is ≥ 2cm in at least one diameter and measured with a ruler.For patients with EMD measurable disease by CT or MRI or the CT portion of the PET/CT: Must have at least one lesion that has a single diameter of ≥ 2 cm. Skin lesions can be used if the area is ≥ 2 cm in at least one diameter and measured with a ruler.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2.

The following laboratory values obtained ≤ 14 days prior to registration:

  • Hemoglobin ≥ 8.0 g/dL;
  • Absolute neutrophil count (ANC) ≥1000/mm^3;
  • Platelet count ≥ 75,000/mm^3;
  • Total bilirubin ≤1.5 x ULN (Exception for Gilbert’s syndrome)
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 x ULN and total alkaline phosphatase ≤ 1.5 x ULN.

EXCEPTION in cases where total alkaline phosphatase is > 1.5 ULN, liver alkaline phosphatase should be performed and be ≤ 1.5 x ULN  

  • PT/INR/aPTT ≤1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy
  • Calculated creatinine clearance ≥50 ml/min using the Cockcroft-Gault formula below:
  • Cockcroft-Gault Equation:

    Creatinine clearance for males = (140
    •age)(weight in kg)(72)(serum creatinine in mg/dL)

    Creatinine clearance for females = (140
    •age)(weight in kg)(0.85)(72)(serum creatinine in mg/dL).

- Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only.

Note: A person of childbearing potential (PCBP) is a
person who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) and must:

- Have 2 negative pregnancy tests as verified by the Investigator prior to starting study treatment and must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact. AND

- Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one
additional effective (barrier) measure of contraception without interruption 28 days prior to starting investigational product, during the study treatment, and for at least 28 days after the last dose of Iberdomide (90 days after the last dose of daratumumab, 7 months after last dose of bortezomib whichever is longer.

- NOTE: Non-childbearing potential is defined as follows (by other than medical reasons):

- >= 45 years of age and has not had menses for > 24 months;

- Patients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation;

- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.  Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure

- Willingness to follow Pregnancy Prevention Program requirements:

- Persons of childbearing potential must agree to use a contraceptive method that is highly effective (with a failure rate of < 1% per year), preferably with low user dependency, during the intervention period and for at least 7 months after
the last dose of study intervention. These patients must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.

- Persons able to father a child must agree that during the treatment intervention period and for 6 months after the last dose of study treatment (to allow for clearance of any altered sperm), the participant will:

- Refrain from donating sperm while on study treatment, during dose interruptions and for at least 6 months following last dose of study treatment, PLUS either:

- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; OR

- Must agree to use contraception/barrier such as a male condom (even if they have undergone successful vasectomy), and when having sexual intercourse with a person of childbearing potential who is not currently pregnant his partner will use an additional highly effective contraceptive method with a failure rate of < 1% per year

- Provide written informed consent

- Negative hepatitis B test (defined by a negative test for hepatitis B surface antigen [HBsAg], or antibodies to hepatitis B surface and/or core antigens [antiHBs or antiHBc)

NOTE: Participants with serologic findings suggestive of HBV vaccination (antiHBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR. Those who are PCR positive will be excluded from the study.

- Willingness to provide mandatory bone marrow specimens for correlative research

- Willing and able to adhere to the study visit schedule and other protocol requirements. Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

- Willing to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment


Exclusion Criteria:


- Monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis

- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:

- Pregnant persons;
- Nursing persons;
- Men or women of childbearing potential who are unwilling to employ adequate contraception.

- Receiving any other concurrent chemotherapy, or any ancillary therapy considered investigational

- Known to be human immunodeficiency virus (HIV) positive, known or suspected active hepatitis C infection or seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]) at screening or within 3 months prior to first dose of study treatment.

NOTE: Participants with resolved hepatitis B infection (ie., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels.  Those who are PCR positive will be excluded. 

EXCEPTION: subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.

- Uncontrolled intercurrent illness including, but not limited to:

- Ongoing or active infection (defined as infection undergoing treatment);

- Active mucosal or internal bleeding;

- Social situations that would limit compliance with study requirements (including drug addiction).

- Known gastrointestinal disease (including difficulty swallowing) or gastrointestinal procedure that could interfere with the oral absorption or tolerance of iberdomide or dexamethasone.

- Unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.

NOTE: Stable non-cirrhotic chronic liver
disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.

- Active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). 

NOTE: Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil inclusion criteria.

- Evidence of cardiovascular disease risk, as defined by any of the following:

- Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.

- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening.

- Class III or IV heart failure as defined by the New York Heart Association functional classification system.

- Uncontrolled hypertension.

- History of life-threatening ventricular arrhythmias.

- Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal. Note that forced expiratory testing (FEV1) is required for subjects with a history of or suspected of having COPD and subjects must be excluded if FEV1 is < 50% of predicted normal.

- Known moderate or severe persistent asthma, or currently has uncontrolled asthma of any classification.

- Acute diffuse infiltrative pulmonary and pericardial disease.

- Unable or unwilling to undergo protocol required thromboembolism prophylaxis .

- Has taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St. John's Wort or related products =< 14 days prior to registration.

- Known allergy to any of the study medications, their analogues or excipients in the various formulations.

- Major surgery =< 14 days prior to registration.

- Plasmapheresis =< 14 days prior to registration.

- Has been treated with an investigational agent (i.e., an agent not commercially available) =< 28 days or 5 half-lives (whichever is longer) prior to registration.

- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.

- Radiotherapy =< 14 days prior to registration.

- NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the iberdomide.

- More than 1 prior cycle of a antimyeloma therapy or corticosteroids for the treatment of multiple myeloma.

- NOTE: Prior corticosteroid use for the treatment of non-malignant disorders is permitted.

- Other co-morbidity which would interfere with patient's ability to participate in trial; e.g., uncontrolled infection, uncompensated heart or lung disease.

- Peripheral neuropathy >= grade 3 on clinical examination or grade 2 with pain during the screening period.

- Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L).

- Gastrointestinal disease that may significantly alter the absorption of iberdomide.

- History of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide.

- The subject has received strong inhibitors or inducers of CYP3A4/5 including grapefruit, St. John's Wort or related products =< 14 days prior to registration.

- The subject has a planned or received immunization with a live or live attenuated vaccine =< 8 weeks prior to registration.

- History of prior malignancies, other than MM, unless the subject has been free of the disease for >= 5 years with the exception of the following noninvasive malignancies:

- Basal cell carcinoma of the skin;
- Squamous cell carcinoma of the skin;
- Carcinoma in situ of the cervix;
- Carcinoma in situ of the breast;
- Incidental histological findings of prostate cancer such as T1a or T1b using the Tumor/Node/Metastasis (TNM) classification of malignant tumors or prostate cancer
that is curative.

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

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

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fMRI of Active DBS Stimulation in Epilepsy

A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy

Steven Messina
All
18 years and over
This study is NOT accepting healthy volunteers
2020-301198-H01-RST
20-006464
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Inclusion Criteria:

  • Patients who have previously undergone anterior thalamic nucleus deep brain stimulation (DBS) for refractory epilepsy.


Exclusion Criteria:

  • Contraindication to MRI; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).
MRI of brain with functional imaging, Device, Deep brain stimulation
Epilepsy
Deep brain stimulation, Functional MRI , MRI, Nervous system, Refractory epilepsy
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HS-19-657, A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET (SORENTO)

A Trial to Assess Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

Thorvardur Halfdanarson
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305363-P01-RST
21-007673
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Inclusion Criteria:


- Male or female patient ≥18 years old

- Histologically confirmed, advanced (unresectable and/or metastatic), and
well-differentiated NET of GEP or presumed GEP origin

- At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1
determined by multiphasic CT or MRI (performed within 28 days before randomization)

- ECOG performance status of 0 to 2


Exclusion Criteria:


- Documented evidence of disease progression while on treatment (including SSAs) for
locally advanced unresectable or metastatic disease

- Known central nervous system metastases

- Consecutive treatment with long-acting SSAs for more than 6 months before
randomization

- Carcinoid symptoms that are refractory to treatment (according to the Investigator's
judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to
treatment with daily doses of ≤600 µg of octreotide IR

- Previous treatment with more than 1 cycle of targeted therapies such as mTOR
inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of
chemotherapy or interferon for GEP-NET

- Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial
embolization within 12 months before screening

- Previously received radioligand therapy (PRRT) at any time

 

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

Eligibility last updated 3/22/23. Questions regarding updates should be directed to the study team contact.

Drug
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Elotuzumab in IgG4-Related Disease (IgG4)

Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)

Shounak Majumder
All
18 years to 70 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-305917-P01-RST
21-009754
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Inclusion Criteria:

  • Participant must be able to understand and provide informed consent and be willing to comply with study procedures and follow up.
  • Are at least 18 years of age and not older than 70 years of age at screening.
  • Meet the ACR/EULAR Classification Criteria for IgG4-RD.
  • Have active disease based at screening on an IgG4-RD RI ≥ 4, with disease manifestations in at least two organ systems.
  • May have newly-diagnosed or relapsing disease at screening. Relapsing disease is defined as IgG4-RD that has previously been in remission but is now active again.
  • May be on treatment or off treatment at the time of screening. If on treatment, must be willing to discontinue those other treatments before the baseline visit.
  • No history of severe allergic reactions to monoclonal antibodies.
  • Female participants of childbearing potential must have a negative pregnancy test upon study entry.
  • Female participants of childbearing potential and male participants with a partner of childbearing potential must agree to consistently and correctly use FDA approved highly effective methods of birth control, for the entire duration of the study.
  • Immunization with one of the FDA authorized or licensed SARS-CoV2 vaccines is required for study entry. Vaccination series must have been completed at least 2 weeks prior to start of study therapy.
  • Participants with COVID-19 infections within the preceding three months must have 2 consecutive negative nasal swab PCR tests performed at least 24 hours apart.


Exclusion Criteria:

  • Presence of a condition other than IgG4-RD that (e.g., asthma) is likely to require systemic Glucocorticoids (GC) for disease control during the period of the trial.
  • Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin.)
  • the following lab values as indicators of hepatic dysfunction:
    • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times the upper limit of normal (ULN);
    • Total bilirubin > two times the ULN unless caused by Gilbert’s disease. Gilbert’s disease with total bilirubin > three times ULN;
    • Serum albumin < 2.5 mg/dL.
  • Evidence of another uncontrolled condition which, in the judgment of the investigator, could interfere with participation in the trial according to the protocol.
  • Active infection requiring hospitalization or treatment with systemic antimicrobial agents within the 30 days prior to randomization.
  • Prior use of rituximab or other B cell depleting agents within 9 months of enrollment unless B cells have been demonstrated to have repopulated.
  • Use of any investigational agent or biologic and non-biologic DMARDSwithin 5 half-lives of the agent (or 6 months if the half-life is unknown) prior to enrollment.
  • Any of the following laboratory tests at the Screening Visit:
    • White blood cell (WBC) count < 3.0 x 10^3/µL;
    • Absolute neutrophil count (ANC) < 1.5 x 10^3/µL;
    • Hemoglobin < 10 g/dL;
    • Platelet count < 75 x 10^9/L;
    • Estimated glomerular filtration rate (eGFR) ≤ 45 ml/minute/1.73m^2.
  • The use of supplemental oxygen at baseline.
  • Positive Quantiferon gold assay. Indeterminate Quantiferon gold assays must be repeated(with same or other interferon gamma release assay (IGRA) per local policy) and shown to be negative. Alternatively, if the Quantiferon gold assay remains indeterminant, a participant must have a negative PPD. Finally, if the participant has had the Bacille Calmette-Guerin (BCG) vaccine or has some other condition complicating the interpretation of TB testing, consultation with infectious disease specialist must be obtained before receipt of the first investigational infusion.
    • Participants diagnosed with latent TB are eligible but must have received appropriate prophylaxis for 30 days before their first investigational infusion.
  • Medical history or serologic evidence at Screening of chronic infections including:
    • Human immunodeficiency virus infection;
    • Hepatitis B as indicated by surface antigen or hepatitis B core antibody positivity;
    • Hepatitis C as indicated by anti-hepatitis C antibody positivity; if a participant is Hepatitis C antibody positive, they will be eligible to participate in the study if he/she is negative for viral load at Screening.
  • Live vaccines within 8 weeks of initiating study therapy.
  • Participantis pregnant or breastfeeding, or planning a pregnancy while enrolled in the study.
  • Substance use disorder, including the recurrent use of alcohol and/or drugs within the past year associated with clinically significant impairment associated with failure to meet major responsibilities at work, school, or home.
  • IgG4-RD that is dominated primarily by advanced fibrotic lesions. Specifically, participants whose disease manifestations consist only of:
    • retroperitoneal fibrosis;
    • fibrosing mediatinitis;
    • sclerosing mesenteritis; and
    • Riedel’s thyroiditis. Participants with these disease manifestations can be included; however, only if they have disease in 2 organ systems that is not of an advanced fibrotic nature and otherwise meet the Inclusion and Exclusion Criteria.

Eligibility last updated 8/11/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Other
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A Phase 1b/2 Study of the PARP Inhibitor Niraparib in Combination With Trastuzumab in Patients With Metastatic HER2+ Breast Cancer

Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

Ciara O'Sullivan
Female
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-306053-P01-RST
21-012614
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Inclusion Criteria:

  • Women age ≥ 18 years.
  • Eastern Cooperative Oncology Group performance status 0-2 (Karnofsky >60%).
  • Patients with metastatic breast cancer.
  • HER2 (human epidermal growth factor receptor 2)-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as:
    • Immunohistochemistry (IHC) score of 3+ and/or positive by ISH (defined by In Situ Hybridization ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Both IHC and ISH assays will be performed; however, only one positive result is required for eligibility.
  • Estrogen/progesterone receptor positive OR negative disease allowed.
  • Patients must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Patients that have failed at least one anti-HER2 therapy in the metastatic setting.
  • Patients must have normal organ and marrow function as defined below:
    • absolute neutrophil count ≥ 1,500/mL;
    • platelets ≥ 100,000/mL;
    • total bilirubin ≤ institutional upper limit of normal (ULN);
    • aspartate aminotransferase (AST)/alanine aminotransferase (ALT) 5 ≤ X institutional ULN;
    • creatinine ≤ institutional ULN OR creatinine clearance ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiogram (preferred) or multigated acquisition (MUGA) scans.
  • Willing and able to comply with the requirements of the protocol.
  • Patient is able to take oral medication.
  • Signed informed consent.
  • Female patients of childbearing potential must be willing to use one highly effective form of hormonal contraception or two effective forms of nonhormonal contraception.
  • Contraception must continue for the duration of study treatment and for 7 months after the last dose of study treatment. The above contraception is not a requirement in the case of any of the following:
    • The patient, or partner of the patient, is surgically sterilized;
    • The female patient is > 45 years of age and is postmenopausal (has not menstruated for at least 12 consecutive months;
    • The patient truly abstains from sexual activity and when this is the preferred option to avoid conception and contraception and/or usual lifestyle of the patient.


Exclusion Criteria:

  • Metastatic breast cancer patients who are HER2 positive and have NOT progressed on at least one prior HER2-targeted therapies for metastatic disease -Patients who have not recovered from CTCAE, v. 4.03 grade 2 or higher toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment. Subjects receiving weekly therapy must have a washout period from prior chemotherapy of as least one week. Washout period for chemotherapy administered every 2, 3, or 4 weeks will be 2, 3, and 4 weeks respectively, provided subject has recovered from toxicities of prior therapy such that retreatment is appropriate.
  • Patients must be at least two weeks from prior RT.
  • Patients must have a one-week washout period from prior hormonal therapy (e.g., testosterone, estrogen, progestin, gonadotropin-releasing hormone antagonist).
  • Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability. No concurrent anti-cancer treatment of any type.
  • Patients with known germline BRCA 1 or BRCA 2 mutations.
  • Patient has undergone prior treatment with a known poly(ADP-ribose) polymerase (PARP) inhibitor.
  • Prior treatment of a total doxorubicin > 360 mg/m^2 (or equivalent).
  • Patient has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [HCV RNA] [qualitative] is detected).
  • Patient has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies). -Chronic immunosuppressive therapies including systemic corticosteroids or concurrent short-term use of immunosuppressive therapies is not allowed. Short- term corticosteroid use must be discontinued at least 2 weeks prior to study treatment.
  • Patients with known grade 2 or greater allergic reactions attributed to compounds of similar chemical or biological composition to niraparib are ineligible for study enrollment.
  • Patients with known grade 2 or greater allergic reactions attributed to compounds of similar chemical or biological composition to herceptin are ineligible for study enrollment.
  • Patient is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment. -History of non-breast malignancies within the 5 years prior to study entry, except for the following:
    • Carcinoma in situ (CIS) of the cervix;
    • CIS of the colon;
    • Melanoma in situ;
    • Basal cell and squamous cell carcinomas of the skin.
  • Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection that requires systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).
  • Cardiopulmonary dysfunction as defined by any of the following prior to randomization:
    • History of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.0) Grade ≥3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria Class ≥ II;
    • Angina pectoris requiring anti-angina medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease -High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block [second degree AV-block Type 2 [Mobitz 2] or third degree AV-block]);
    • Significant symptoms (Grade ≥ 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia;
    • Myocardial infarction within 12 months prior to randomization.
  • Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg).
  • Evidence of transmural infarction on ECG.
  • Heart-rate corrected QT interval (QTc) prolongation > 470 msec at screening.
  • Requirement for oxygen therapy.

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

 

Biologic/Vaccine, Drug
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A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors

A Study of HFB200301 in Adult Patients With Advanced Solid Tumors

Konstantinos Leventakos
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-306800-P01-RST
22-000038
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Inclusion Criteria:


- Previously received the following lines of systemic therapy for the
advanced/metastatic disease:

- Gastric cancer: at least 2 lines of therapy

- Renal cell carcinoma: at least 2 lines of therapy

- Melanoma:

- BRAF V600E mutant: must have received at least 2 lines of therapy

- BRAF V600E wild type: must have received at least 1 line of therapy

- Sarcoma: at least 1 line of therapy

- Testicular germ cell tumor: at least 2 lines of therapy

- Cervical cancer: at least 2 lines of therapy

- Mesothelioma: at least 2 lines of therapy

- Non-small cell lung cancer: at least 3 lines of therapy

- Head and neck squamous cell carcinoma: at least 2 lines of therapy

- Suitable site to biopsy at pre-treatment and on-treatment

- Measurable disease as determined by Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 or modified RECIST (mRECIST) for mesothelioma

- Eastern Cooperative Oncology Group performance status of 0 or 1


Exclusion Criteria:


- Systemic anti-cancer therapy within 2 weeks prior to start of study drug

- For soft tissue sarcoma and testicular germ cell tumor patients only: prior immune
therapy

- Therapeutic radiation therapy within the past 2 weeks

- Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2)
receptor

- Active autoimmune disease requiring systemic treatment in the previous 2 years

- Systemic steroid therapy (>10 mg/day of prednisone or equivalent) or any immune
suppressive therapy

- Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) relating to prior anti cancer
therapy with the following exceptions:

- All grades of alopecia are acceptable

- Endocrine dysfunction on replacement therapy is acceptable

- Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy,
or unstable psychiatric condition

- Major surgery within 2 weeks of the first dose of study drug

- History or presence of drug or non-drug induced interstitial lung disease or
pneumonitis ≥Grade 2

- History of allergic reactions, immune related reactions, or cytokine release syndrome
(CRS) attributed to compounds of similar chemical or biologic composition to
monoclonal antibodies or any excipient of HFB200301

- Using sensitive substrates of major cytochrome P450 (CYP450) enzymes

- Known active malignancy, with the exception of the specific cancer under investigation
in this trial, that required treatment within the previous 2 years

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

Eligibility last updated 11/15/22. Questions regarding updates should be directed to the study team contact.

Drug
Cancer, Cervical cancer, Germ cell tumor, Head and neck cancer, Hypopharyngeal cancer, Kidney cancer, Laryngeal cancer, Lung cancer, Melanoma, Mesothelioma, Metastatic melanoma, Sarcoma, Skin cancer, Soft tissue sarcoma, Stomach cancer, Testicular cancer, Throat cancer
Cancer treatment, Digestive system, Epstein-Barr virus associated gastric carcinoma, Integumentary system, Medical Oncology, Musculoskeletal system, Reproductive system, Respiratory system, Targeted drug therapy, Urinary system
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Obesity-Induced Dysfunction of Human MSC in Peripheral Microvascular Repair

Dysfunction of Mesenchymal Stem/Stromal Cells Induced by Obesity

Lilach Lerman
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
2022-307980-H01-RST
22-004291
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Inclusion Criteria:

  • Group 1:
    • Age 18-80 years;
    • BMI ≥ 35 kg/m^2;
    • Eligible for bariatric surgery;
    • Ability to provide consent.
  • Group 2:
    • Age 18-80 years;
    • BMI ≤ 30 kg/m^2;
    • Undergoing live donor nephrectomy;
    • Ability to provide consent.


Exclusion Criteria:
 

  • Pregnancy.
  • Chronic Inflammatory Disease (e.g., rheumatoid arthritis).
  • Active malignancy.
  • Recent stroke or myocardial infarction.
  • Solid organ transplant recipients.
  • Therapeutic doses of immunosuppressive drugs (including calcineurin inhibitors and prednisone (> 10 mg/day).
  • Senolytic supplements.
  • Subjects on therapeutic doses of anticoagulants [including Warfarin (Coumadin), Rivaroxaban (Xarleto); Apixaban (Eliquis); Dabigatran (Pradaxa, Prazaxa)].
  • Subjects deemed ineligible to comply with study protocol.
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(ECTx) C4401001 / A Phase I Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PF-07257876 in Patients with Advanced or or Metastatic Tumors

Study to Test the Safety and Tolerability of PF-07257876 in Participants with Selected Advanced Tumors

Saravut Weroha
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305495-P01-RST
21-008170
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Inclusion Criteria:


- Histological/cytological diagnosis of selected advanced or metastatic tumor

- Prior treatment with PD-1 (Programmed cell death 1) or PD-L1 (programmed death-ligand
1) in NSCLC and SCCHN or platinum-based therapy in Ovarian cancer

- Confirmed radiographic progression of disease

- PD-L1 IHC positivity ≥1%

- Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously
irradiated

- Eastern Cooperative Oncology Group performance status 0-1

- Adequate hematologic, renal and liver functions

- Resolved acute effects of any prior therapy

- Participants in Part 1 must be able to provide archival tumor tissue collected within
the prior 6 months or consent to undergo a fresh biopsy during screening. Participants
enrolled to the MTD (Maximum Tolerated Dose) cohort in Part 1 must consent to
mandatory paired pre-treatment and on-treatment biopsies. Participants in Part 2 must
consent to a pre-treatment biopsy and a subset of patients must consent to a paired
on-study biopsy as well until the Sponsor deems an adequate number have been received.


Exclusion Criteria:


- Participants with known brain metastasis larger than 4 cm or that is symptomatic. New
brain metastases detected at screening. Participants with previously diagnosed brain
metastases are eligible if they have completed treatment and recovered from acute
effects prior to study entry.

- Abnormal neurological assessment by investigator

- Other active malignancy within 3 years prior to enrollment, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ

- Major surgery or radiation therapy within 4 weeks prior to planned first dose

- Last systemic anti-cancer therapy within 28 days or 5 half-lives (whichever is
shorter) prior to planned first dose (6 weeks for mitomycin C or nitrosoureas)

- Active bleeding disorder in the past 6 months prior to first dose

- History of clinically significant severe immune mediated adverse event that was
considered related to prior immune modulatory therapy and required immunosuppressive
therapy (other than hormone replacement therapy)

- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced
pneumonitis, organizing pneumonia (ie, bronchiolitis obliterans, cryptogenic
organizing pneumonia), evidence of active pneumonitis on screening chest CT(computer
tomography) scan

- Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed

- Treatment with chronic systemic corticosteroids or other immunosuppressive medications

- Participation in other studies involving investigational drug(s) within 4 weeks prior
to planned first dose

- Active, uncontrolled bacterial, fungal, or viral infection, Hepatitis B, Hepatitis C,
or Human immunodeficiency virus (HIV) infection

- Active COVID-19/SARS-CoV2

- Pregnant or breastfeeding female participant

- Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow
or hematopoietic stem cell transplant

- Significant cardiac or pulmonary conditions or events within previous 6 months

Eligibility last updated  2/21/23. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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MarkVCID Validation in the General Community (MarkVCID2)

Validation of MarkVCID in the General Community

Ronald Petersen
All
60 years to 90 years old
This study is NOT accepting healthy volunteers
2021-305868-H01-RST
21-009529
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Inclusion Criteria:

  • Male or female.
  • Aged 60 to 90 years, inclusive at Visit 1 Screen.
  • Clinical diagnosis of normal cognition, subjective cognitive decline, mild cognitive impairment or mild dementia ( CDR® ≤ 1.5).
  • Fluent in English or Spanish.


Exclusion Criteria:

  • Contraindications to MRI such as inability to fit inside the MRI scanner, difficulty with close or confined spaces or presence of MRI non-compatible implants such as pacemakers or aneurysm clips.
  • History of or current neurologic, psychiatric or medical disease that could confound the results of the study tests and procedures.
  • Clinical diagnosis of moderate or severe cognitive impairment or dementia, requiring assistance with basic activities of daily living.

Eligibility last updated 2/17/22.  Questions regarding updates should be directed to the study team contact.

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Remote Monitoring with Health-Coaching for Lifestyle Changes in Patients with Lung Cancer Related Fatigue

Remote Monitoring for Lifestyle Changes in Patients with Lung Cancer Related Fatigue

Roberto Benzo
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306737-P01-RST
21-013228
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosed with advanced NSCLC being treated with any line of non-curative intent, systemic treatment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2.
  • The ability to read and respond to questions in English or Spanish.
  • Receiving primary cancer care at Mayo Clinic, Rochester or MCHS.
  • Life expectancy at least 6 months.


Exclusion Criteria:

  • Individuals < 18 years.
  • Patients wioth cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.

Eligibility last updated 12/21/21. Questions regarding updates should be directed to the study team contact.

Behavioral
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Quantification of Symptom Relief Following Percutaneous Ablation of the Thyroid

Measuring Symptom Relief After Radiofrequency Ablation of the Thyroid

Thomas Atwell
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308891-H01-RST
22-007581
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Inclusion Criteria:

  • ≥ 18 years of age. 
  • Undergoing Radiofrequency Ablation (RFA) for symptomatic thyroid nodule(s).


Exclusion Criteria:

  • < 18 years of age.
  • Decline to participate in research. 

Eligibility last updated 7/20/22. Questions regarding updates should be directed to the study team contact.

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Development and Validation of a New Disease-Specific Quality of Life Index for Sporadic Vestibular Schwannoma

A Study to Develop and Validate a New Disease-Specific Quality of Life Index for Sporadic Vestibular Schwannoma

Kathleen Yost
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304151-H01-RST
21-003059
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Inclusion Criteria:

  • Able to read and write English fluently.
  • Can sign consent for themselves.
  • Age 18 years or older.
  • Diagnosis of sporadic Vestibular Schwannoma (VS) (also called acoustic neuroma).


Exclusion Criteria:

  • Age less than 18 years old.
  • Diagnosis of VS secondary to neurofibromatosis type 2 (NF2).
  • Lack of capacity to consent.
  • Unable to read/write English fluently.
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Evaluation of the Cardiac and Metabolic Effects of Semaglutide in Heart Failure with preserved Ejection Fraction (CAMEO-SEMA) A Phase II, Prospective, Double-Blind Randomized Trial (CAMEO SEMA)

Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction

Barry Borlaug
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306933-H01-RST
22-000522
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Inclusion Criteria:

Subjects are eligible to be randomized in the study only if all of the following inclusion criteria and none of the exclusion criteria apply.

To mirror the STEP-HFpEF trials CAMEO-SEMA will utilize essentially the same entry criteria, except for an EF cutoff. CAMEO-SEMA will use an EF value of ≥ 50% (rather than ≥ 45%) to define HFpEF, to harmonize with the recently published universal definition of HFpEF.59.

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  • Age ≥ 18 years at the time of signing informed consent.
  • BMI ≥ 30.0 kg/m^2.
  • NYHA Class II-IV.
  • LVEF ≥ 50 % within the preceding year.
  • No hospitalizations due to heart failure in the preceding 30 days.
  • At least one of the following:
    • Mean PCWP ≥ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≥ 15 mmHg documented during catheterization at rest, or PCWP or LVEDP ≥ 25 mmHg documented during catheterization at exercise;
    • If BMI < 35.0: NT-proBNP ≥ 220 pg/mL (for patients with sinus rhythm) or NT-proBNP ≥ 660 pg/mL (for patients with persistent/permanent atrial fibrillation); if BMI ≥ 35.0: NT-proBNP ≥ 125 pg/mL (for patients in sinus rhythm) or NT-proBNP ≥ 375 pg/mL (for patients with persistent/ permanent atrial fibrillation) at screening (NT-proBNP analyzed by the central laboratory) in combination with at least one of the following (documented by echocardiography within 12 months prior to or at screening):
      • Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15;
      • PA systolic pressure > 35 mmHg;
      • Left atrial (LA) enlargement (LA width ≥ 3.8 cm or LA length ≥ 5.0 cm or LA area ≥ 20.0 cm^2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2);
      • LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm.
    • Hospitalization with a primary diagnosis of decompensated heart failure which required intravenous (IV) loop diuretic treatment, within the previous 12 months in combination with at least two of the following (documented by echocardiography within 12 months prior to or at screening):
      • Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15;
      • PA systolic pressure > 35 mmHg;
      • LA enlargement (LA width ≥ 3.8 cm or LA length ≥  5.0 cm or LA area ≥ 20.0 cm^2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2);
      • LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm;
      • Ongoing use of diuretic therapy for at least 30 days prior to screening.


Exclusion Criteria:

  • Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
  • Systolic blood pressure > 160 mmHg at screening.
  • Planned coronary, carotid or peripheral artery revascularization.
  • Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, anemia, or more than moderate heart valve disease).
    • Amyloid cardiomyopathy may be present in 5-15% of patients presenting with the clinical syndrome of HFpEF,60-62 and patients with amyloid may respond differently to WL intervention. To enhance the scientific rigor of the trial by ensuring a homogenous population of true primary HFpEF, we will carefully evaluate for the presence of amyloid using the approach outlined in a recent scientific statement from the AHA,63 which is also consistent with our current clinical practice.
  • Specifically, potential participants will be evaluated for clues or risk factors for underlying cardiac amyloid including intolerance to antihypertensives, hypotension, orthostatic intolerance, persistent low-grade elevation in troponin, low QRS voltage on ECG, unexplained AV block or prior pacemaker, unexplained LV or RV wall thickening, impaired LV global longitudinal strain with apical sparing by echocardiography, family history of cardiomyopathy, neuropathy, autonomic dysfunction, carpal tunnel syndrome,  lumbar spinal stenosis, family history of polyneuropathy, or black race. Patients with these risk factors will undergo screening evaluation for amyloid prior to consent in CAMEO-SEMA as part of best clinical practice.  This includes screening for monoclonal light chain as first step, followed by hematology consultation if the screen is positive.  Patients with risk factors but no monoclonal light chain will then undergo Tc-99m-PYP scan to rule out cardiac amyloid.
  • Bariatric surgery prior to screening within 5 years of screening  or planned bariatric surgery within the trial time course.
  • A self-reported change in body weight > 5 kg (11 lbs.) within 90 days before screening irrespective of medical records.
  • HbA1c ≥ 10.0% based on latest available value from medical records, not older than 3 months.
  • History of type 1 diabetes (history of gestational diabetes is allowed).
  • Treatment with any GLP-1 receptor agonist within 90 days prior to the day of screening.
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • Presence of acute pancreatitis within the last 180 days prior to screening.
  • History or presence of chronic pancreatitis.
  • End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis.
  • Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed.
  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Participation in any clinical trial of an approved or non-approved device for the treatment of heart failure or obesity within 30 days before screening.
  • Receipt of any investigational medicinal product within 30 days before screening.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
  • Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
  • Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
  • The criteria will be assessed at the investigator’s discretion unless otherwise stated.

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

Eligibility last updated 12/27/23. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug, Other
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Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS Registry)

Prospective Evaluation Analysis and Kinetics Registry (PEAKS)

Abhishek Deshmukh
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306583-P01-RST
21-012967
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Inclusion Criteria:

  • Adults age 18 years and older.
  • Eligible for the use of elective intravenous sotalol loading to treat atrial arrhythmias, per the treating clinician.
  • IV sotalol infusion started for the treatment of atrial arrhythmias, in the setting of initiation or dose titration of chronic sotalol therapy.
  • Elective hospital admission primarily for loading with intravenous sotalol with/without cardioversion, with no other planned therapy or procedures .


Exclusion Criteria:

  • Study materials not available in the subject’s preferred language.
  • Patients undergoing treatment for active concomitant ventricular arrhythmias.
  • Standard exclusions for elective sotalol use (at the time of initiation):
    • Heart rate < 40 bpm or 2nd/3rd degree AV block without pacemaker;
    • QTc ≥ 450 in absence of bundle branch block (≥ 500 in the presence of a bundle branch block);
    • Severe left ventricular hypertrophy (thickness > 1.5 cm).
  • Patients who were previously intolerant to antiarrhythmic class III therapy.
  • Patients missing key data elements in their electronic health record (for retrospective subjects only).

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

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A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Intravenous ANX005 in Subjects With Warm Autoimmune Hemolytic Anemia (wAIHA) (ANX005 - wAIHA)

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Subjects With Warm Autoimmune Hemolytic Anemia (wAIHA)

Ronald Go
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2020-302704-P01-RST
20-010764
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Inclusion Criteria:


- Male or non-pregnant, non-lactating female ≥18 years of age (no maximum age).

- Diagnosis of wAIHA at least 3 months prior to screening with a direct antiglobulin
test (DAT) ≥1 positive for immunoglobulin G (IgG)±C3, or a diagnosis of mixed
autoimmune hemolytic anemia (AIHA) that is DAT positive for both IgG and C3, with a
presence of a cold antibody with a thermal amplitude ≥30ºCelcius.

- Hemoglobin (Hgb) level ≤10.0 grams/deciliter (pre-transfusion).

- Evidence of classical complement pathway activation.

- Evidence of active hemolysis.

- Stable use of glucocorticoids and immunosuppressants are permitted.

- Vaccinations against encapsulated bacterial organisms within 5 years prior to
screening or participant must be willing to receive prophylaxis against infections
with encapsulated bacteria via vaccination and/or the use of prophylactic antibiotics
in accordance with local standards of practice and/or guidelines.


Exclusion Criteria:


- Elevated aspartate aminotransferase or alanine aminotransferase levels >2.5 times the
upper limit of normal.

- Platelet count <30 X 10^9/liter.

- History of cold agglutinin disease.

- History of solid organ, bone marrow, or stem cell transplantation.

- History of splenectomy within the 3 months prior to screening.

- Received rituximab or other anti-CD20 monoclonal antibody <3 months prior to
screening.

- Intravenous immunoglobulin (IVIg) treatment within 3 months prior to screening or
plasmapheresis or immunoadsorption treatment within 60 days prior to screening.

- Clinically significant, recent, or ongoing illness or medical condition, including
coexistent autoimmune disorder, malignancy, HIV, hepatitis B virus, and hepatitis C
virus.

- History of meningitis or septicemia within the past 2 years.

- Treatment with an investigational therapeutic agent within 30 days prior to screening.

- Hypersensitivity to any drug product or excipients used in this study or to previous
IV medication administration.

- Body weight less than 50 kilograms (kg) or greater than 100 kg.

Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.

Drug
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