Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

Phase 3 Terminated 48 enrolled QED Therapeutics, a BridgeBio company Helsinn Healthcare SA · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2019-12-27
Primary completion: 2023-03-02
Completion: 2023-03-02

Outcome

Outcome not reported

Stopped: “The sponsor has decided to close the study due to the discontinuation of infigratinib development in oncology within the sponsor's territory. The discontinuation of the study was not due to safety issues.”

Publications

Makawita S, K Abou-Alfa G, Roychowdhury S, Sadeghi S, Borbath I, Goyal L, Cohn A, Lamarca A, Oh DY, Macarulla T, T Shroff R, Howland M, Li A, Cho T, Pande A, Javle M. Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial. Future Oncol. 2020 Oct;16(30):2375-2384. doi: 10.2217/fon-2020-0299. Epub 2020 Jun 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Comparator	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Infigratinib	Small molecule	125 mg	Oral