(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
{ "Phase 3 Study of CGT9486 + Sunitinib for Advanced GIST", "This Phase 3 study is testing a new combination treatment, CGT9486 and sunitinib, for people with advanced gastrointestinal stromal tumors (GIST). Researchers want to see how well this combination works compared to sunitinib alone. The study will also look at how CGT9486 and sunitinib interact in the body. You may be eligible if you have locally advanced, metastatic (spread to other parts of the body), or unresectable GIST. The study aims to enroll about 482 participants and will measure drug levels in the body as a primary goal.", "design": "This is an open-label (you and your doctors will know which treatment you are receiving), international, multi-part Phase 3 study involving approximately 482 participants.", "commitments": "Participants will receive CGT9486 and/or sunitinib orally until study stopping rules are met. Some participants will also receive a single dose of midazolam on Day 1 and Day 16.", "compensation": "Not stated in the trial record.", "follow_up": "Drug levels (Cmax and AUC) will be measured at 14 or 16 days, but overall follow-up duration is not specified.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
At a glance
Conditions
Where it's being run
126 sites across 48 statesWho to contact
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Inclusion
What this trial measures
- Part 1a - pharmacokinetics - Cmax16 days
Maximum plasma concentration (Cmax)
- Part 1a - pharmacokinetics - AUC16 days
Area under the plasma concentration-time curve (AUC)
- Part 1b - pharmacokinetics - Cmax14 days
Maximum plasma concentration (Cmax)
- Part 1b - pharmacokinetics - AUC14 days
Area under the plasma concentration-time curve (AUC)
- Part 1b - pharmacokinetics - Tmax14 days
Time to maximum observed plasma concentration (Tmax)
- Part 2 - Progression Free Survival (PFS)Approximately 48 months
Time from first dose to documented disease progression or death due to any cause, whichever occurs first
- DDI Substudy - pharmacokinetics - AUC16 days
Area under the plasma concentration-time curve (AUC)
- DDI Substudy - pharmacokinetics - Cmax14 days
Maximum plasma concentration (Cmax)