Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: The PROOF 301 trial Journal Article


Authors: Makawita, S.; Abou-Alfa, G. K.; Roychowdhury, S.; Sadeghi, S.; Borbath, I.; Goyal, L.; Cohn, A.; Lamarca, A.; Oh, D. Y.; MacArulla, T.; Shroff, R. T.; Howland, M.; Li, A.; Cho, T.; Pande, A.; Javle, M.
Article Title: Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: The PROOF 301 trial
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. © 2020 Future Medicine Ltd.
Keywords: targeted therapy; cholangiocarcinoma; fibroblast growth factor receptor inhibitor; infigratinib
Journal Title: Future Oncology
Volume: 16
Issue: 30
ISSN: 1479-6694
Publisher: Future Medicine  
Date Published: 2020-10-01
Start Page: 2375
End Page: 2384
Language: English
DOI: 10.2217/fon-2020-0299
PUBMED: 32580579
PROVIDER: scopus
DOI/URL:
Notes: Review -- Export Date: 1 December 2020 -- Source: Scopus
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  1. Ghassan Abou-Alfa
    570 Abou-Alfa