FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements.

Future Oncology
T S Bekaii-SaabArndt Vogel

Abstract

FGFR2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma (CCA) tumorigenesis, and occur almost exclusively in intrahepatic CCA. Pemigatinib, a selective, potent, oral inhibitor of FGFR1-3, has demonstrated efficacy and safety in a Phase II study of patients with previously treated locally advanced/metastatic CCA harboring FGFR2 fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, Phase III study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA with FGFR2 rearrangements (NCT03656536). The primary end point is progression-free survival; secondary end points are objective response rate, overall survival, duration of response, disease control rate, safety and quality of life. Clinical Trial Registration: NCT03656536 (ClinicalTrials.gov).

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Nov 24, 2020·Expert Opinion on Investigational Drugs·Leonardo BaiocchiGianfranco Alpini
Nov 19, 2020·Cancers·Nicola PersoneniLorenza Rimassa
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Mar 13, 2021·Visceral Medicine·Arndt Vogel, Anna Saborowski

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Clinical Trials Mentioned

NCT02591030
NCT02924376
NCT03656536
NCT03230318
NCT04087876
NCT04238715
NCT02699606
NCT04093362
NCT02150967
NCT03773302

Software Mentioned

FoundationOne

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