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(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
NCT05208047 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05208047
The ClinicalTrials.gov registry entry for NCT05208047 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 442 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cogent Biosciences, which has 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05208047 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05208047?
The interventions under investigation include: Midazolam (DRUG), Sunitinib (DRUG), CGT9486 plus sunitinib (DRUG), CGT9486 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05208047?
This trial is sponsored by Cogent Biosciences, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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