Infigratinib in patients with advanced cholangiocarcinoma with gene fusions/translocations: the PROOF 301 trial.
(2020) Future Oncology — Vol. 16, n° 30, p. 2375-2384 (2020)
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- Authors
Makawita, Shalini 
K Abou-Alfa, Ghassan Roychowdhury, Sameek Sadeghi, Saeed Javle, Milind
- Abstract
- Cholangiocarcinoma is an aggressive malignancy with poor overall survival. Approximately 15% of intrahepatic cholangiocarcinomas contain alterations. Infigratinib is an oral FGFR 1-3 kinase inhibitor. Favorable results from a Phase II trial of infigratinib in advanced/metastatic -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 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).
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Citations
Makawita, S., K Abou-Alfa, G., Roychowdhury, S., Sadeghi, S., Borbath, I., Goyal, L., Cohn, A., Lamarca, A., Oh, D.-Y., Macarulla, T., T Shroff, R., Howland, M., Li, A., Cho, T., Pande, A., & Javle, M. (2020). Infigratinib in patients with advanced cholangiocarcinoma with gene fusions/translocations: the PROOF 301 trial. Future Oncology, 16(30), 2375-2384. https://doi.org/10.2217/fon-2020-0299 (Original work published 2020)