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

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    Authors
    Bekaii-Saab, T. S.
    Valle, Juan W
    Cutsem, E. V.
    Rimassa, L.
    Furuse, J.
    Ioka, T.
    Melisi, D.
    Macarulla, T.
    Bridgewater, J.
    Wasan, H.
    Borad, M. J.
    Abou-Alfa, G. K.
    Jiang, P.
    Lihou, C. F.
    Zhen, H.
    Asatiani, E.
    Féliz, L.
    Vogel, A.
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    Affiliation
    Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, AZ 85054,
    Issue Date
    2020
    
    Metadata
    Show full item record
    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). Keywords: FGFR; INCB054828; cholangiocarcinoma; pemigatinib.
    Citation
    Bekaii-Saab TS, Valle JW, Cutsem EV, Rimassa L, Furuse J, Ioka T, et al. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020.
    Journal
    Future Oncology
    URI
    http://hdl.handle.net/10541/623189
    DOI
    10.2217/fon-2020-0429
    PubMed ID
    32677452
    Additional Links
    https://dx.doi.org/10.2217/fon-2020-0429
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.2217/fon-2020-0429
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