Thank you for your interest in the PROOF clinical research trial.
This is a multicenter, open-label, randomized, controlled, Phase 3 trial to evaluate the efficacy of infigratinib vs gemcitabine with cisplatin based on centrally assessed progression-free survival (PFS) in subjects with advanced/metastatic or inoperable cholangiocarcinoma with FGFR2 fusions/translocations.
Subjects will be randomized in a 1:1 ratio to receive oral infigratinib administered once daily for the first 3 weeks (21 days) of a 28-day treatment cycle compared to a regimen of gemcitabine with cisplatin given intravenously on Days 1 and 8 of a 21-day cycle.
Patients must meet the following inclusion criteria*:
- Histologically or cytologically confirmed, nonresectable, recurrent, or metastatic cholangiocarcinoma. Measurable disease not required for eligibility
- Positive test results for FGFR2 gene fusions/translocations
Note: Central lab confirmation is not required prior to enrollment in the trial.
*This only represents select inclusion criteria for the trial.
Infigratinib—oral, once daily
Intravenous gemcitabine with cisplatin
With singular focus, QED is devoted to the development of infigratinib. A first-in-class, selective, tyrosine kinase inhibitor, infigratinib* is being developed to treat patients with FGFR-driven cholangiocarcinoma and metastatic urothelial carcinoma.
*Infigratinib is an investigational product and is not currently approved for use in any indication.