Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
Phase 3
200
about 2.7 years
18+
19 sites in CA, FL, IL +10
What this study is about
Researchers are testing whether Tinengotinib, either 10 mg or 8 mg, is better than the standard treatment (Physician's Choice) for people with cholangiocarcinoma whose cancer cells have changes in the FGFR gene. The trial will last about 985 days and involve approximately 200 participants.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Physician's Choice
- 2.Take Tinengotinib 10 mg
- 3.Take Tinengotinib 8 mg
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
kinase inhibitor
Primary: Part A: Incidence, duration, and severity of adverse events (AEs), Part B: PFS by BICR
Secondary: Part A: DOR by Investigator, Part A: ORR by Investigator, Part B: Duration of Response (DOR) by BICR and by Investigator, Part B: Objective Response Rate (ORR) by BICR and by Investigator:, Part B: PFS by Investigators per RECIST v1.1., Part B:Overall Survival (OS)