Trial Identifiers
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Scientific Title
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
Commercial Sponsor
QED Therapeutics, Inc.
Summary
Patients eligible to participate in this trial will receive daily oral doses of Infigratinib for three weeks of a 4 week cycle, or intravenous administration of Gemcitabine and Cisplatin on Day 1 and 8 of a 21 day cycle. Patients receiving Gemcitabine and Cisplatin, who experience cancer progression will be able to receive Infigratinib instead.