EUCTR2012-000305-76-FR进行中（未招募）1 期
A phase Ib/II open-label, multi-center study of the combination of MEK162 plus AMG 479 (ganitumab) in adult patients with selected advanced solid tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
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
- 性别
- All
入选标准
- •Patients aged = 18 years
- •Patients with advanced solid tumors (CRC, melanoma) with
- •documented somatic KRAS or BRAFV600 mutations in tumor tissue.
- •Patients with metastatic pancreatic adenocarcinoma may be enrolled
- •irrespectively of KRAS or BRAFV600 mutational status.
- •Patients must have relapsed or progressed following standard
- •or patients for whom no standard anticancer therapy exists.
- •Measurable disease as determined by RECIST v1.1. World Health
- •Organization (WHO) Performance Status (PS) = 2.
- •Adequate organ function
- •Negative serum pregnancy test
- •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 59
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •Prior therapy with MEK- or IGF-1R- inhibitor
- •History or current evidence of central serous retinopathy (CSR), retinal
- •vein occlusion (RVO) or retinal degenerative disease
- •Patients with known history of severe infusion reactions to monoclonal
- •Patients with primary CNS tumor or CNS tumor involvement
- •History of thromboembolic event requiring full-dose anticoagulation
- •Clinically significant cardiac disease
- •History of another malignancy within 2 years
- •Pregnant or nursing (lactating) women
- •Other protocol-defined exclusion criteria may apply
研究者
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