拜耳启动Stivarga III期COAST研究

拜耳启动Stivarga III期COAST研究
[size=1.1em]作者：[size=1.1em]tomato[size=1.1em]来源：[size=1.1em]生物谷2014-2-21   关键词： 拜耳 Stivarga regorafenib 结直肠癌

                               
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2014年2月21日讯 /生物谷BIOON/ --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。（生物谷Bioon.com）

英文原文：Bayer Initiates Phase III Trial of Regorafenib in Patients with Colorectal Cancer after Resection of Liver Metastases

Berlin, February 20, 2014 – Bayer HealthCare today announced that the company has begun to enroll patients in the COAST trial studying regorafenib (Stivarga?) tablets in colorectal cancer (CRC) patients with resected liver metastases. The randomized, double-blind, placebo-controlled Phase III trial is evaluating regorafenib as adjuvant treatment of colorectal cancer following resection of liver metastases with curative intent.

“The COAST trial is another step forward in Bayer’s ongoing commitment to explore the full clinical potential of regorafenib for colorectal cancer patients across different stages of this disease,” said Dr. J?rg M?ller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “Many patients with advanced colorectal cancer that has metastasized to the liver experience disease recurrence despite curative surgery and are in need of new treatment options.”

Phase III Trial Design
The COAST (Patients with Stage IV COlorectal Cancer treated with Adjuvant Regorafenib Versus Placebo after Curative Treatment of Liver Metastases in A Randomized, Double-blind, Placebo-controlled Phase-III Study) clinical trial is studying regorafenib in patients with colorectal cancer after curative resection of liver metastases and completion of all planned chemotherapy. The study will investigate whether providing oral regorafenib in the adjuvant setting increases disease-free survival (DFS) and overall survival (OS). The trial will enroll approximately 750 patients who will be randomized in a 1:1 ratio to receive either 160 mg regorafenib or placebo. Safety and tolerability of the treatment groups will be continuously monitored.

The study will be conducted in North America, Brazil, Europe, Asia, Israel and Australia.

About Colorectal Cancer
Colorectal Cancer (CRC) is the third most common cancer worldwide, with over one million cases occurring every year. The five-year survival estimate for CRC on average is 55 percent, but is highly variable dependent on the stage of the disease (from 74 percent for patients with Stage I disease to only 6 percent for Stage IV patients).

About Stivarga?
Stivarga? (regorafenib) is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression – angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). In addition to VEGFR 1-3 it also inhibits various oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression.

Stivarga is approved in the United States, Europe, Japan, and in several other countries for the treatment of metastatic CRC. For the treatment of gastrointestinal stromal tumors (GIST), Stivarga is also approved in the United States, Japan and in several other countries. In September 2013, Bayer submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the treatment of patients with GIST.

Stivarga is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc., an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of Stivarga in oncology.

(责任编辑：lishuheng)