NCT03773302

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: QED Therapeutics, a BridgeBio company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cholangiocarcinoma
• FGFR2 Gene Mutation

Interventions

Type	Name	Description
DRUG	BGJ398	Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
DRUG	Cisplatin	Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.

Timeline

• Start date: 2019-12-27
• Primary completion: 2023-03-02
• Completion: 2023-03-02
• First posted: 2018-12-12
• Last updated: 2024-05-08
• Results posted: 2024-05-08

Locations

116 sites across 15 countries: United States, Australia, Belgium, Canada, China, France, Germany, Italy, Portugal, Puerto Rico, South Korea, Spain, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study