NCT05948475
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatmentTransThera Sciences (Nanjing), Inc.
~200 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Tinengotinib 8 mgTinengotinib 10 mgPhysician's Choice
At a glance
Recruiting sites
0 of 87 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Incidence, duration, and severity of adverse events (AEs)
Measured over Up to 30 days from study discontinuation
+1 more outcome measured
Conditions
Where it's being run
87 sites across 28 statesItaly13
Spain12
France8
South Korea8
Germany6
Taiwan5
United Kingdom4
California3
Study leadership
- Milind Javle, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Part A: Incidence, duration, and severity of adverse events (AEs)Up to 30 days from study discontinuation
As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).
- Part B: PFS by BICRFrom first study drug administration until the date of first documented progression assessed by BICR or date of death from any cause, whichever came first, assessed up to 24 months
Progression-free survival (PFS) by BICR: PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or date of death due to any cause, whichever is earlier.