JPRN-UMIN000031857已完成未知
A multi-center proof-of-concept phase2 study of encorafenib + binimetinib + cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer - BIG BANG Study
ational Cancer Center Hospital Eas0 个研究点目标入组 36 人开始时间: 2018年4月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.History of treatment with epidermal growth factor receptor (EGFR) inhibitors including anti-EGFR antibody drugs 2.History of treatment with BRAF inhibitors or MEK inhibitors 3.History of treatment with regorafenib 4.Symptomatic brain metastases or meningeal dissemination 5.Leptomeningeal disease 6.Medical history, current condition, or risk of retinal vein occlusion 7.Inadequately controlled diabetes requiring insulin therapy 8.Acute or chronic pancreatitis 9.Medical history of clinically significant cardiac diseases 10.Gastrointestinal function or gastrointestinal diseases that significantly interfere with absorption, distribution, metabolism, and excretion of the study drugs 11.No history of other malignant tumors within 3 years before the start of study treatment. In cases of lesions corresponding to carcinoma in situ and intramucosal carcinoma judged to be cured by local therapy, non-metastatic prostate cancer not requiring systemic therapy, and other solid cancers that do not require therapy or are not estimated to be adversely affected by the study treatment, patients will not be excluded from the study when the coordinating committee concludes after consultation that there is no effect on the patient's prognosis. 12.Medical history of thromboembolism within 6 months 13.Concurrent neuromuscular disorder that is associated with the potential of elevated CK 14.Previous treatment with any of the following, a.cyclical chemotherapy within a period of 14 days b.bevacizumab, aflibercept, or ramucirumab within 3 weeks c.biologic therapy (except bevacizumab, aflibercept, or ramucirumab), immunotherapy, marketed small molecular compounds, or non marketed investigational anticancer treatments within 4 weeks, or within a period 5fold the halflife (whichever is shorter) d.prior radiotherapy to 30% of bone marrow
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