(Peak) A Clinical Study of CGT9486+Sunitinib vs Sunitinib in Patients with Gastrointestinal Stromal Tumors
EU CTIS ID: 2022-500637-80-00
What this study is testing
Part 2: To determine the efficacy of bezuclastinib+sunitinib vs sunitinib in subjects with GIST
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed locally advanced, metastatic, and/or unresectable GIST (Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization.)
- Documented disease progression on or intolerance to imatinib. Imatinib intolerance is defined as discontinuation of imatinib due to (an) adverse event(s) related to treatment with imatinib that was not manageable with dose modifications.
- Subjects must have received the following treatment: − Part 1a: Treatment with ≥1 prior lines of therapy for GIST − Part 1b: Treatment with ≥2 prior TKI for GISTs. (Note: Each different TKI is counted once regardless of how often it was used. If 2 different TKIs were used in combination, both TKIs are counted.) − Part 2: Prior treatment with imatinib only
- Have at least 1 measurable lesion according to mRECIST v1.1 (non-nodal lesions must be ≥1.0 cm in the long axis or ≥double the slice thickness in the long axis)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- other protocol defined inclusion criteria apply
You likely can't join if
- Prior anticancer drug less than 5 half-lives of the parent drug and/or its active metabolite(s) or 14 days (whichever is shorter) prior to the first dose of study drug.
- Known hypersensitivity to components of bezuclastinib or sunitinib
- Known PDGFR driving mutations or known succinate dehydrogenase deficiency
- Clinically significant cardiac disease
- other protocol defined exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Chile
- Hong Kong
- United States
- Canada
- Turkey
- Argentina
- Australia
- Taiwan
- United Kingdom
- Brazil
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Chile; Hong Kong; United States; Canada; Turkey and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.