(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
Recruiting now · Phase 3
Conditions studied: Advanced Gastrointestinal Stromal Tumors, Metastatic Cancer
In brief
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for Gastrointestinal Stromal Tumors (GIST) and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. This study also contains two substudies: 1) a drug-drug interactions (DDI) substudy will investigate the potential for CGT9486 to be a Cytochrome P450 (CYP)3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST and 2) a substudy intended to test the efficacy of bezuclastinib and sunitinib as first-line (1L) treatment of GIST in approximately 40 participants with KIT exon 9 mutations and no prior systemic therapy (with the exception of up to 10 subjects with ongoing imatinib therapy of ≤4 weeks).
Key facts
- Study ID
- NCT05208047
- Run by
- Cogent Biosciences, Inc.
- People needed
- 482
- Starts
- 2022-04-14
- Expected to finish
- 2030-01-01
- Last updated by the study team
- 2026-06-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Orlando Health Cancer Institute — Orlando, Florida, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Nebraska Methodist Hospital — Omaha, Nebraska, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- University of California, San Francisco — San Francisco, California, United States
- Mid Florida Hematology and Oncology Center — Orange City, Florida, United States
- University of California, San Diego (UCSD) — San Diego, California, United States
- University of Arizona- Cancer Center — Tucson, Arizona, United States
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States
- University of California, Los Angeles (UCLA) — Los Angeles, California, United States
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- University of Kansas Cancer Center — Kansas City, Kansas, United States
- Mayo Clinic — Rochester, Minnesota, United States
- University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
- University of Colorado Denver — Denver, Colorado, United States
- City of Hope — Duarte, California, United States
- Mayo Clinic — Scottsdale, Arizona, United States
- Duke University — Durham, North Carolina, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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