Phase 3Terminated
Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial
- Sponsor
- QED Therapeutics, a BridgeBio company (Industry)
- Enrollment
- 48 enrolled
- Conditions
- Advanced Cholangiocarcinoma; FGFR2 Gene Mutation
- Interventions
- BGJ398; Gemcitabine; Cisplatin
- Ages
- adults, older adults
- Registry
- NCT03773302, EUCTR2018-004004-19
Full record on ClinicalTrials.gov
From the registry
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.
Primary outcomes
- Progression-free Survival (Central Imaging Assessment)
History
Results first posted
Last registry update
Primary completion
Started
Registered