EUCTR2007-004806-28-FR进行中（未招募）1 期
An Open-label Phase II Clinical trial of Panitumumab in Combination with Irinotecan for Patients with Advanced Metastatic Colorectal Cancer without KRAS mutation (Wild type) in third line chemotherapy (Patients pretreated with FOLFOX or XELOX ± bevacizumab and irinotecan alone or FOLFIRI or CAPIRI ± bevacizumab) - PIMABI
GERCOR0 个研究点目标入组 69 人开始时间: 2008年1月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 69
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 confirmed metastatic adenocarcinoma of the colon or rectum by the Investigator.
- •Wild Type KRAS (no mutation) by allelic discrimination on tumor DNA
- •Prior chemotherapy regimens for mCRC with oxaliplatin and Fluorpyrimidines (5FU/FA or capecitabine) ± Bevacizumab and Irinotecan alone or in association with Fluorpyrimidines (5FU/FA or capecitabine) ± Bevacizumab
- •At least 1 uni-dimensionally measurable lesion of at least 10 mm per modified-RECIST criteria (All sites must be evaluated = 28 days prior to the enrolment).
- •Prior radiotherapy is acceptable. It must be at least 14 days since administration of radiation therapy and all signs of early toxicity must have abated.
- •World Health Organisation (WHO) performance status of 0, 1 or 2
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia (treated or not)
- •Presence of KRAS mutation by allelic discrimination on tumor DNA
- •Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib). Subjects who discontinue their first dose of anti-EGFR therapy (cetuximab) because of an infusion reaction may participate in this clinical trial.
- •Prior radiotherapy within 14 days since administration of radiation therapy to enrollment. All signs of early toxicity must have abated.
- •Metastases of the central nervous system
- •Pregnancy ; breast feeding
研究者
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