A phase I-II study of BIBF 1120 and Folfox compared to Bevacizumab and Folfox in first line metastatic colorectal cancer patients. - BIBF 1120 vs Bevacizumab in CRC

SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 120 人开始时间: 2009年2月27日最近更新: 2017年8月21日

试验速览

暂无简介。

•- Age >= 18 years
•- Histologically proven colorectal adenocarcinoma
•- No previous oxaliplatin based chemotherapy unless disease free survival after the end of chemotherapy is >= 12 months
•- No previous therapy with VEGFR or EGFR inhibitors
•- No prior systemic therapy for metastatic CRC
•- No previous adjuvant therapy with fluoropyrimidines unless disease free survival after the end of chemotherapy is >= 6 months
•- ECOG performance status =< 2
•- Adequate hepatic, renal and bone marrow functions
•- No uncontrolled hypertension
•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

•- Known hypersensitivity to the trial drugs or their excipients
•- Treatment with any investigational drug within 28 days of trial onset
•- History of other malignancies in the last 5 years
•- Serious concomitant disease
•- Major injuries and /or bone fracture within 4 weeks of trial inclusion or planned surgical procedures during the trial period
•- Significant cardiovascular disease
•- History of severe haemorrhagic or thromboembolic event in the past 12 months
•- Patient who require full-dose anticoagulation (INR>2.5)
•- Pregnancy or breast feeding

发起方

SCS Boehringer Ingelheim Comm.V