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Study to evaluate the efficacy and safety of oral tinengotinib compared to physician's choice in subjects with recurrent/resistant fibroblast growth factor receptor (FGFR)-disrupted cholangiocarcinoma ...
THE MAIN GOAL OF THIS STUDY IS TO FIND OUT HOW WELL TINENGOTINIB WORKS AND HOW SAFE TINENGOTINIB IS COMPARED TO THE STUDY DOCTOR'S CHOICE OF CHEMOTHERAPY TREATMENT. THIS STUDY WILL BE DIVIDED INTO 2 PARTS: PART A AND PART B. THE PURPOSE OF PART A OF THE STUDY WILL BE TO DETERMINE THE BEST DOSE OF TINENGOTINIB TO USE IN PART B OF THE STUDY. THE PURPOSE OF PART B IS TO GET MORE INFORMATION ABOUT HOW TINENGOTINIB WORKS AND ITS SAFETY COMPARED TO THE STUDY DOCTOR'S CHOICE OF TREATMENT.
Technical Summary
- PHASE III, RANDOMIZED, CONTROLLED, MULTICENTER, GLOBAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL TINENGOTINIB COMPARED TO PHYSICIAN'S CHOICE IN SUBJECTS WITH CHOLANGIOCARCINOMA WITH ALTERED FIBROBLAST GROWTH FACTOR RECEPTOR (FGFR) RELAPSED/REFRACTORY TO CHEMOTHERAPY AND FGFR INHIBITORS (FIRST-308)
- Code EudraCT: 2023-505660-11-00
- Protocol number: TT420C2308
- Promoter: TransThera Sciences (Nanjing), Inc.
- Molecule/Drug: Tinengotinib
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