Phase 2: testing Belzutifan for Pheochromocytoma/Paraganglioma
This is a study to measure the how well it works and safety of belzutifan this drug alone in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to measure the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Official registry: https://clinicaltrials.gov/study/NCT04924075 · Merck Sharp & Dohme LLC · enrollment listed as 355
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Belzutifan. The registry lists allocation as na. This is a study to measure the how well it works and safety of belzutifan this drug alone in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations.
They plan to enroll about 355 people at 85 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With HIF-2α Related Genetic Alterations
Interventions: Belzutifan
Primary outcome (registry wording): Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
Who it is for (from inclusion criteria)
- Ages 12 Years to any
- The main include but are not limited to the following:
- Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1)
- Cohort B1: VHL Disease-associated tumors:
- Have a diagnosis of VHL disease as determined by a germline test locally and/or clinical diagnosis
- Must be ≥18 years of age
- Has a life expectancy of at least 3 months
Who the registry excludes
- include but are not limited to the following:
- Unable to swallow orally administered medication or has a disorder that might affect the absorption of belzutifan
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- Any of the following: A pulse oximeter reading \<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, or arterial bypass (CABG) or Percutaneous transluminal coronary angioplasty (PTCA) ≤6 months from study entry, or New York Heart Association Class III or IV congestive heart failure
- Received prior treatment (except somatostatin analogs) with chemotherapy, targeted therapy, biologics, or other investigational therapy within the past 4 weeks of first dose of study intervention
Public study contact (from the registry)
Toll Free Number
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
85 listed- Cedars-Sinai Medical Center ( Site 0110) — Los Angeles, California (recruiting)
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130) — Chicago, Illinois (recruiting)
- Northwestern Medicine Cancer Center - Warrenville ( Site 0134) — Warrenville, Illinois (recruiting)
- University of Iowa ( Site 0104) — Iowa City, Iowa (recruiting)
- Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108) — Baltimore, Maryland (recruiting)
- National Institutes of Health ( Site 0125) — Bethesda, Maryland (recruiting)
- Massachusetts General Hospital ( Site 0111) — Boston, Massachusetts (recruiting)
- University of Michigan ( Site 0126) — Ann Arbor, Michigan (recruiting)
- Washington University-Internal Medicine/Oncology ( Site 0124) — St Louis, Missouri (active_not_recruiting)
- Icahn School of Medicine at Mount Sinai ( Site 0123) — New York, New York (active_not_recruiting)
- Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127) — Philadelphia, Pennsylvania (active_not_recruiting)
- SCRI Oncology Partners ( Site 7000) — Nashville, Tennessee (completed)
+ 71 sites outside the US on the same record
FAQ about this NCT record
Is NCT04924075 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT04924075?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT04924075?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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