Ghassan K. Abou-Alfa, MD, discusses key eligibility criteria for the phase 3 PROOF trial in cholangiocarcinoma.
Ghassan K. Abou-Alfa, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, discusses key eligibility criteria for the phase 3 PROOF trial (NCT03773302) in cholangiocarcinoma.
The PROOF study is evaluating oral infigratinib (BGJ398) as first-line treatment for patients with cholangiocarcinoma whose tumors harbor FGFR2 gene fusions or translocations.
The study is ongoing and currently recruiting patients.
Eligible patients have to have a confirmed diagnosis of unresectable locally advanced or metastatic cholangiocarcinoma with a confirmed FGFR2 gene fusion or translocation, says Abou-Alfa. Additionally, patients have to have an available tissue sample for molecular testing, an ECOG performance status of 0 or 1, be able to swallow and retain oral medication, and a willingness to avoid pregnancy or fathering children.
Exclusion criteria include prior systemic therapies, a history of liver transplant, and prior FGFR or MEK inhibitor therapy, among other criteria that could influence outcomes, Abou-Alfa concludes.