| Literature DB >> 32580579 |
Shalini Makawita1, Ghassan K Abou-Alfa2,3, Sameek Roychowdhury4, Saeed Sadeghi5, Ivan Borbath6, Lipika Goyal7,8, Allen Cohn9, Angela Lamarca10, Do-Youn Oh11, Teresa Macarulla12, Rachna T Shroff13, Michael Howland14, Ai Li14, Terry Cho14, Amit Pande14, Milind Javle1,15.
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).Entities:
Keywords: cholangiocarcinoma; fibroblast growth factor receptor inhibitor; infigratinib; targeted therapy
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Year: 2020 PMID： 32580579 DOI： 10.2217/fon-2020-0299
Source DB: PubMed Journal: Future Oncol ISSN： 1479-6694 Impact factor: 3.404