drugset / Trial / NCT04093362
Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced, metastatic, or recurrent unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements
Timeline
- Start
- 2021-01-06
- Primary completion
- 2024-04-22
- Completion
- 2024-04-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Futibatinib | Small molecule | 20 mg | Oral |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |