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瑞派替尼对比舒尼替尼用于伊马替尼治疗后进展的晚期胃肠间质瘤的 III 期研究。

Intrigue: Phase III study of ripretinib versus sunitinib in advanced gastrointestinal stromal tumor after imatinib.

机构信息

The University of Toledo College of Medicine & Life Sciences, Toledo, OH 43606, USA.

ProMedica Health System, Toledo, OH 43606, USA.

出版信息

Future Oncol. 2020 Jan;16(1):4251-4264. doi: 10.2217/fon-2019-0633. Epub 2019 Nov 22.

Abstract

Ripretinib (DCC-2618) is a novel, type II tyrosine switch control inhibitor designed to broadly inhibit activating and drug-resistant mutations in and . Ripretinib has emerged as a promising investigational agent for the treatment of gastrointestinal stromal tumor owing to targeted inhibition of secondary resistance mutations that may develop following treatment with prior line(s) of tyrosine kinase inhibitors. Here we describe the rationale and design of intrigue (NCT03673501), a global, randomized (1:1), open-label, Phase III study comparing the safety and efficacy of ripretinib versus sunitinib in patients with advanced gastrointestinal stromal tumor following imatinib. The primary end point is progression-free survival and key secondary objectives include objective response rate and overall survival. Clinical Trial Registration: NCT03673501.

摘要

瑞普替尼(DCC-2618)是一种新型的 II 型酪氨酸开关控制抑制剂,旨在广泛抑制 和 中的激活和耐药突变。由于靶向抑制可能在先前的酪氨酸激酶抑制剂治疗后发展的继发耐药突变,瑞普替尼已成为治疗胃肠道间质瘤的一种有前途的研究药物。在这里,我们描述了 intrigue 研究(NCT03673501)的原理和设计,这是一项全球性、随机(1:1)、开放标签、III 期研究,比较了瑞普替尼与舒尼替尼在伊马替尼治疗后晚期胃肠道间质瘤患者中的安全性和疗效。主要终点是无进展生存期,关键次要终点包括客观缓解率和总生存期。临床试验注册:NCT03673501。

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