A Proposal for BMS-354825 (Dasatinib) in GIST：建议BMS-354825（达沙替尼）在胃肠道间质瘤.ppt

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2018-06-23 发布于浙江
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A Proposal for BMS-354825 (Dasatinib) in GIST：建议BMS-354825（达沙替尼）在胃肠道间质瘤.ppt

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A Proposal for BMS-354825 (Dasatinib) in GIST：建议BMS-354825（达沙替尼）在胃肠道间质瘤

A Proposal for BMS-354825 (Dasatinib) in GIST Jon Trent, MD, PhD Assistant Professor Dept. of Sarcoma Medical Oncology The University of Texas, M. D. Anderson Cancer Center BMS-354825 (Dasatinib) BMS-354825 (Dasatinib) Mult-targeted oncogenic kinase inhibitor Fyn, Yes, Src, Lck, Bcr-Abl, Epha-2, Kit, PDGFR, 100X potent than imatinib Binds ABL in active and inactive conformation Dasatinib in imatinib-resistant CML Most Commonly Reported Non-Hematologic Toxicity BMS-354825 (Dasatinib) in GIST Phase I study (N=19, 9 GIST) Primary Endpoint Dose/schedule: safe at 90 mg BID 5d/2d Secondary Endpoint PET imaging: 1 response CT imaging: 5 SD 7-17 weeks A Proposal for BMS-354825 (Dasatinib) in GIST Jon Trent, MD, PhD Assistant Professor Dept. of Sarcoma Medical Oncology The University of Texas, M. D. Anderson Cancer Center BMS-354825 (Dasatinib) in GIST: Inclusion Criteria Histologically confirmed diagnosis of GIST Refractory or relapsed disease after adequate imatinib. Imatinib-intolerant Generalized or limited progression BMS-354825 (Dasatinib) in GIST: Evaluations Choi criteria will be used for response endpoints Tumor size decrease of 10% or tumor density decrease of 15% RECIST will be recorded for all patients BMS-354825 (Dasatinib) in GIST: Design Two-arm phase IIa trial to simultaneously monitor safety and efficacy. A 20% response rate with less than a 15% rate of toxicity is targeted. Trial is terminated early if toxicity is high or efficacy is low. Safety and Efficacy Progression-free survival and overall survival Regression analyses to assess the ability of patient prognostic factors to predict time-to-event outcomes A Proposal for BMS-354825 (Dasatinib) in GIST Jon Trent, MD, PhD Assistant Professor Dept. of Sarcoma Medical Oncology The University of Texas, M. D. Anderson Cancer Center Choi Criteia BMS-354825 (Dasatinib) in Imatinib-resistant CP-CML N=36 (31 resistant, 5 intolerant) 15 to 180 mg/d for 5-7 d/wk 27 pts with mutations Responses:- Hematol