Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial
Makawita, S Abou-Alfa, GK Roychowdhury, S Sadeghi, S Borbath, I Goyal, L Cohn, A Lamarca, Angela Oh, DY Macarulla, T
Makawita, S
Abou-Alfa, GK
Roychowdhury, S
Sadeghi, S
Borbath, I
Goyal, L
Cohn, A
Lamarca, Angela
Oh, DY
Macarulla, T
Citations
Altmetric:
Abstract
Cholangiocarcinoma is an aggressive malignancy with poor overall survival. Approximately 15% of intrahepatic cholangiocarcinomas contain FGFR alterations. Infigratinib is an oral FGFR 1-3 kinase inhibitor. Favorable results from a Phase II trial of infigratinib in advanced/metastatic FGFR-altered cholangiocarcinomas has led to its further investigation in the front-line setting. In this article we describe the design, objectives and rationale for PROOF 301, a Phase III multicenter, open label, randomized trial of infigratinib in comparison to standard of care gemcitabine and cisplatin in advanced/metastatic cholangiocarcinoma with FGFR2 translocations. The results of this study have the potential to define a new role for a chemotherapy-free, targeted therapy option in the front-line setting for these patients. Clinical Trial Registration: NCT03773302 (ClincalTrials.gov).
Keywords: cholangiocarcinoma; fibroblast growth factor receptor inhibitor; infigratinib; targeted therapy.
Description
Date
2020
Publisher
Collections
Keywords
Type
Article
Citation
Makawita S, G KA-A, Roychowdhury S, Sadeghi S, Borbath I, Goyal L, et al. Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial. Future Oncol. 2020.