A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib VS Physician's Choice in Subjects With FGFR-altered, Chemotherapy- and FGFR Inhibitor-Cholangiocarcinoma
TransThera Sciences (Nanjing), Inc.
Summary
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma
Description
Approximately 200 subjects will be enrolled. Eligible subjects will be randomized in a 2:2:1 ratio to receive tinengotinib 8 mg QD, tinengotinib 10 mg QD or Physician's Choice in Part A; and eligible subjects will be randomized in a 2:1 ratio to receive the recommended Part B dose or selected dose or Physician's Choice in Part B.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease. 3. Documentation of FGFR2 fusion/rearrangement gene status 4. Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor. Exclusion Criteria: 1. Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs. 2. Subjects with known brain or central nervous system (CNS) metas…
Interventions
- DrugTinengotinib 8 mg
Subjects randomized to receive tinengotinib will receive a starting dose of either 8 mg QD., self-administered orally QD in 28-day cycles.
- DrugTinengotinib 10 mg
Subjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles.
- DrugPhysician's Choice
For subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle.
Locations (87)
- UCLA Medical CenterSanta Monica, California
- Stanford Cancer CenterStanford, California
- The University of Kansas Cancer CenterWestwood, Los Angeles, California
- Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
- The University of Chicago HospitalsChicago, Illinois
- UMass Memorial Medical CenterWorcester, Massachusetts