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NCT05208047 · ClinicalTrials.gov registry record · Phase 3
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
A Phase 3 study of Metastatic Cancer and Advanced Gastrointestinal Stromal Tumors, sponsored by Cogent Biosciences.
- Active
- Registry status
- Phase 3
- Development phase
- 442
- Enrollment target
- 20
- Study locations
NCT05208047: Active Phase 3 study of Metastatic Cancer and Advanced Gastrointestinal Stromal Tumors, sponsored by Cogent Biosciences.
NCT05208047 is a Phase 3 study of Metastatic Cancer and Advanced Gastrointestinal Stromal Tumors that is active but no longer recruiting, run by Cogent Biosciences. The registered enrollment target is 442 participants, roughly in line with the 440-participant average among 109 other Metastatic Cancer trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05208047, a Phase 3 study of Metastatic Cancer and Advanced Gastrointestinal Stromal Tumors, is active but no longer recruiting, sponsored by Cogent Biosciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 442 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 442 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 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. Additionally, a drug-drug interactions substudy will investigate the potential for CGT9486 to be a CYP3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST.
Primary Outcome
Maximum plasma concentration (Cmax)
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Sunitinib
- DRUG CGT9486 plus sunitinib
- DRUG CGT9486
Study Locations (20)
California
- City of Hope - Duarte
- University of California, Los Angeles (UCLA) - Los Angeles
- University of California, San Diego (UCSD) - San Diego
- University of California, San Francisco - San Francisco
Florida
- Mayo Clinic Jacksonville - Jacksonville
- University of Miami - Sylvester Comprehensive Cancer Center - Miami
- Orlando Health Cancer Institute - Orlando
- Moffitt Cancer Center - Tampa
Arizona
- Mayo Clinic - Scottsdale
- University of Arizona- Cancer Center - Tucson
Colorado
- University of Colorado Denver - Denver
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Illinois
- Northwestern University - Chicago
Iowa
- University of Iowa Hospital and Clinics - Iowa City
Kansas
- University of Kansas Cancer Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2022-04-14 |
| Est. Completion | 2026-09 |
| Phase | Phase 3 |
What the registry record for NCT05208047 still lists
NCT05208047 is an interventional study that assigns participants to a tested intervention. The registered 442 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 440-participant average among 109 other Metastatic Cancer trials with a reported enrollment target.
The record links to 2 conditions, with Metastatic Cancer appearing as the primary indexed condition, and to 4 interventions - of which Midazolam is the first listed.
NCT05208047 names 20 study sites across 13 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05208047 about?
NCT05208047 is a clinical study titled "(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors". 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 442 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent p...
What is the current status of trial NCT05208047?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 442 participants. The study started on 2022-04-14. Estimated completion is 2026-09.
What conditions does trial NCT05208047 study?
This clinical trial studies the following conditions: Metastatic Cancer, Advanced Gastrointestinal Stromal Tumors.
What interventions are being tested in trial NCT05208047?
The interventions under investigation include: Midazolam (DRUG), Sunitinib (DRUG), CGT9486 plus sunitinib (DRUG), CGT9486 (DRUG).
Who is sponsoring clinical trial NCT05208047?
This trial is sponsored by Cogent Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05208047 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05208047's enrollment target sits among peer trials
442 10th of 109 higher than 99 of 109 other Metastatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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