拜耳启动Stivarga III期COAST研究

2014-02-21 tomato 生物谷

拜耳(Bayer)2月20日宣布,已启动抗癌药Stivarga(regorafenib)III期COAST研究的患者招募。COAST是一项随机、双盲、安慰剂对照试验,将招募750例已根治性切除肝转移且已完成所有已计划化疗疗程的结直肠癌(CRC)患者,研究中患者将以1:1的比例,随机接受160mg regorafenib或安慰剂。该项研究将调查regorafenib用于辅助治疗是否能提高无病生存率(

拜耳(Bayer)2月20日宣布,已启动抗癌药Stivarga(regorafenib)III期COAST研究的患者招募。COAST是一项随机、双盲、安慰剂对照试验,将招募750例已根治性切除肝转移且已完成所有已计划化疗疗程的结直肠癌(CRC)患者,研究中患者将以1:1的比例,随机接受160mg regorafenib或安慰剂。该项研究将调查regorafenib用于辅助治疗是否能提高无病生存率(DFS)和总生存期(OS)。研究中,将连续监测regorafenib的安全性和耐受性。该项研究将在北美、巴西、欧洲、亚洲、以色列及澳大利亚开展。

许多晚期结直肠癌患者,尽管已手术根除性切除肝转移,仍会经历病情的复发,这一患者群体亟需新的治疗选择。拜耳开展COAST研究,其目的便是探索regorafenib用于结直肠癌不同疾病阶段治疗的临床潜力。

Stivarga是首个也是唯一一种在转移性结直肠癌(mCRC)中表现出总生存期益处的多激酶抑制剂,目前,该药已获欧盟、美国、日本等国批准用于转移性结直肠癌(mCRC)的治疗,同时已获美国、日本批准用于胃肠道间质瘤(GIST)的治疗。

在全球范围内,结直肠癌(CRC)是第三种最常见的癌症,每年发生超过100万例,5年生存率平均为55%。

Stivarga是一种口服多激酶抑制剂,在临床前研究中,regorafenib能够抑制数个促血管生成VEGF受体酪氨酸激酶,这些激酶在肿瘤的血管生成中发挥着重要作用。该药还可以抑制癌和肿瘤微环境中的多种激酶,包括VEGFR 1-3, KIT, RET, PDGFR及FGFR。


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    2014-04-07 circumcision
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    2014-08-13 juliusluan78
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    2014-02-23 ying_wu
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