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-2a related Genetic Alterations

Phase 1

Recruiting

• Conditions: Pheochromocytoma, Paraganglioma, Pancreatic Neuroendocrine Tumors, von Hippel-Lindau (VHL) Disease-Associated Tumors, Gastrointestinal Stromal Tumor (wt GIST), Solid Tumors With HIF-2a related Genetic Alterations.; MedDRA version: 21.0Level: LLTClassification code: 10067518Term: Pancreatic neuroendocrine tumor Class: 10029104; MedDRA version: 20.0Level: LLTClassification code: 10073860Term: Paraganglioma Class: 10029104; MedDRA version: 20.0Level: PTClassification code: 10047716Term: Von Hippel-Lindau disease Class: 100000004850; MedDRA version: 20.1Level: LLTClassification code: 10034876Term: Pheochromocytoma Class: 10029104; MedDRA version: 20.0Level: LLTClassification code: 10062427Term: Gastrointestinal stromal tumor Class: 10029104; MedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-504853-11-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-15
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

Male and Female participants at least 12 years of age (at least 18 years of age for Cohort B1)., Diagnosis of one of the following: Advanced/metastatic pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumors (pNET), von Hippel-Lindau (VHL) disease associated localized tumors, or advanced wild-type gastrointestinal stromal tumor (wt GIST) or advanced solid tumors with Hypoxia Inducible Factor- 2 alpha subunit (HIF-2a) related genetic alterations., Cohort BI: 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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified