國家衛生研究院 NHRI:Item 3990099045/12269

NHRI > National Institute of Cancer Research > Li-Tzong Chen > Conference Papers/Meeting Abstract > Item 3990099045/12269

Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/12269

Title:	A phase II trial of TAS-120 in patients with intrahepatic cholangiocarcinoma harboring FGFR2 gene rearrangements
Authors:	Goyal, L;Bahleda, R;Furuse, J;Valle, JW;Moehler, MH;Oh, DY;Chang, HM;Kelley, RK;Javle, MM;Borad, MJ;Chen, LT;Uboha, NV;Klumpen, HJ;O'Dwyer, PJ;Li, DN;Morizane, C;Huang, J;Bridgewater, JA
Contributors:	National Institute of Cancer Research
Abstract:	Background: Intrahepatic cholangiocarcinoma (iCCA) is a cancer arising from the intrahepatic bile duct. Standard treatment of unresectable, recurrent, or metastatic iCCA is with cytotoxic chemotherapy. FGFR2 gene fusions have been identified as oncogenic drivers in 10–20% of iCCA tumors, but no targeted agents have been established to date. TAS-120 is an investigational irreversible FGFR1–4 inhibitor in development as a once-daily oral treatment for iCCA. Based on initial studies in multiple tumor types expressing FGFR abnormalities, iCCA was identified as a tumor type with potential susceptibility to FGFR inhibition and high unmet need. A phase I portion of the trial with an iCCA expansion cohort demonstrated tolerability and preliminary evidence of clinical efficacy with TAS-120 as a continuous, once-daily oral treatment in patients with iCCA. The most common AEs in the phase I portion of the trial were hyperphosphatemia, a mechanism-based on-target side effect, cutaneous AEs, and gastrointestinal AEs. The phase I portion of the study is continuing to enroll, and final results are anticipated in early 2019. Based on preliminary findings, a phase II portion of the study (FOENIX-101; clinicaltrials.gov registration NCT02052778) has been initiated. Methods: The phase II portion of the trial is a global, single-arm study of TAS-120 in patients with iCCA harboring FGFR2 gene rearrangements. The study will enroll approximately 100 adult patients with locally advanced or metastatic iCCA that progressed after ≥ 1 systemic therapies and with an ECOG PS of 0 or 1. Prior systemic therapy must include gemcitabine plus platinum-based chemotherapy. Screening for FGFR2 gene rearrangements will be performed at a central laboratory. The primary endpoint is objective response rate based on RECIST v1.1. Secondary endpoints include duration of response, disease control rate, overall survival, progression-free survival, safety, and health-related quality of life. Clinical trial information: NCT02052778.
Date:	2019-02
Relation:	Journal of Clinical Oncology. 2019 Feb;37(4, Suppl.):Abstract number TPS468.
Link to:	http://dx.doi.org/10.1200/JCO.2019.37.4_suppl.TPS468
JIF/Ranking 2023:	http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0732-183X&DestApp=IC2JCR
Cited Times(WOS):	https://www.webofscience.com/wos/woscc/full-record/WOS:000489107600022
Appears in Collections:	[Li-Tzong Chen] Conference Papers/Meeting Abstract

Files in This Item:

There are no files associated with this item.

Loading...