EUCTR2012-002138-35-DE进行中(未招募)1 期
A phase Ib/II multi-center, open-label, dose escalation study of LGX818 and cetuximab or LGX818, BYL719, and cetuximab in patients with BRAF mutant metastatic colorectal cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Metastatic colorectal cancer
- •- Progression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimens
- •- Life expectancy = 3 months
- •- ECOG performance status = 1
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •- Symptomatic or untreated leptomeningeal disease
- •- Symptomatic brain metastasis
- •- Patients with clinically manifested diabetes
- •- Acute or chronic pancreatitis
- •- Clinically significant cardiac disease
- •Other protocol-defined exclusion criteria may apply
研究者
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