Available | Phase III
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
The PROOF Trial is a clinical research study to determine if the investigational drug, infigratinib, is an effective treatment for cholangiocarcinoma compared with the standard of care, chemotherapy gemcitabine with cisplatin, for patients with a genetic abnormality in the Fibroblast Growth Factor Receptor (FGFR) gene.
Arm 1: Infigratinib, study agent, (oral medication)
Arm 2: Gemcitabine with Cisplatin
Key Participation Requirements:
Male or Female
19 years and older
FGFR-2 gene mutation
Nonresectable, recurrent, metastatic, or advanced cholangiocarcinoma
Patients must sign an approved informed consent and authorization permitting release of personal health information.
Methodist Health System Trial Code:
For more information, visit the U.S. National Library of Medicine clinical trial database.
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