作者
Ho Yeong Lim, Jeong Heo, Hye Jin Choi, Cheng-Yao Lin, Jung-Hwan Yoon, Chiun Hsu, Kun-Ming Rau, Ronnie TP Poon, Winnie Yeo, Joong-Won Park, Miah Hiang Tay, Wen-Son Hsieh, Christian Kappeler, Prabhu Rajagopalan, Heiko Krissel, Michael Jeffers, Chia-Jui Yen, Won Young Tak
发表日期
2014/12/1
期刊
Clinical Cancer Research
卷号
20
期号
23
页码范围
5976-5985
出版商
American Association for Cancer Research
简介
Purpose: There is an unmet need for treatment options in hepatocellular carcinoma (HCC). Sorafenib is currently the only approved systemic treatment for HCC. Refametinib, an oral, allosteric MEK inhibitor, has demonstrated antitumor activity in combination with sorafenib in vitro and in vivo. A phase II study evaluated efficacy and safety of refametinib plus sorafenib in Asian patients with HCC (NCT01204177).
Experimental Design: Eligible patients received twice-daily refametinib 50 mg plus twice-daily sorafenib 200 mg (morning)/400 mg (evening), with dose escalation to sorafenib 400 mg twice daily from cycle 2 if no grade ≥2 hand-foot skin reaction, fatigue, or gastrointestinal toxicity occurred. Primary efficacy endpoint: disease control rate. Secondary endpoints: time to progression, overall survival, pharmacokinetic assessment, biomarker analysis, safety, and tolerability.
Results …
引用总数
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