EUCTR2011-005547-27-ES进行中（未招募）不适用
A PHASE II, MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF FOLFIRI + MEHD7945A VERSUS FOLFIRI + CETUXIMAB IN SECOND LINE IN PATIENTS WITH KRAS WILD-TYPE METASTATIC COLORECTAL CANCER
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •?Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum cancer with wildtype Kras status
- •?Progressive disease on or after a first-line oxaliplatin-containing chemotherapy regimen for mCRC
- •?Availability and willingness to provide archival tumor tissue for biomarker testing
- •?Age ?18 years
- •?Male and female
- •?Life expectancy ?12 weeks
- •?ECOG 0 or 1
- •?Disease that is measurable per RECIST v1.1
- •?Adequate hematologic and end-organ function
- •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 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •?Prior treatment with irinotecan
- •?Prior treatment with an investigational or approved HER-targeted agent
- •?Last anti tumor therapy within 4 weeks prior to Day 1 of the study treatment with exception of oxaliplatin-containing chemotherapy and palliative radiotherapy
- •?Leptomeningeal disease as the only manifestation of the current malignancy
- •?Major surgical procedure within 4 weeks prior to Day 1 of the study treatment
- •?Current severe, uncontrolled systemic disease
- •?History of cardiac heart failure of any New York Heart Association criteria or serious cardiac arrhythmia requiring treatment
- •?History of myocardial infarction within 6 months prior to Day 1 of the study treatment, or history of unstable angina
- •?Clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; or current alcohol abuse
- •?Clinically significant gastrointestinal bleeding within 6 months prior to Day 1 of the study treatment
- •?History of ILD
- •?History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of therapy
- •?Untreated or progressing CNS metastases
- •?Women during pregnancy or lactation
研究者
相似试验
进行中（未招募）
不适用
Study of the investigational drug MEHD7945A compared to the anticancer drug cetuximab when combined with standard chemotherapy in patients with colorectal cancer without mutation in the KRAS gene (Kras wild type).EUCTR2011-005547-27-DEGenentech, Inc.120
进行中（未招募）
不适用
Study of the investigational drug MEHD7945A compared to the anticancer drug cetuximab when combined with standard chemotherapy in patients with colorectal cancer without mutation in the KRAS gene (Kras wild type).EUCTR2011-005547-27-ITGENENTECH , INC120
进行中（未招募）
不适用
Study of the investigational drug MEHD7945A compared to the anticancer drug cetuximab when combined with standard chemotherapy in patients with colorectal cancer without mutation in the KRAS gene (Kras wild type).EUCTR2011-005547-27-BEGenentech, Inc.120
进行中（未招募）
1 期
Study of the investigational drug MEHD7945A compared to the anticancer drug cetuximab when combined with standard chemotherapy in patients with colorectal cancer without mutation in the KRAS gene (Kras wild type).EUCTR2011-005547-27-GBGenentech, Inc.134
进行中（未招募）
1 期
A Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients with Non-Small Cell Lung Cancer After Platinum FailureEUCTR2013-001142-34-GBF. Hoffmann-La Roche. Ltd.287