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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared to mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.;Secondary Objective: - Efficacy of BIBF 1120: overall survival, PFS, Overall response rate, resection rate and tumour shrinkage<br>- Safety <br>- Pharmacokinetic<br>- Quality of life<br>- Biomarkers analysis (VEGF, FGF, PDGF plasma levels, oncogene profile);Primary end point(s): The primary enpoint will assess:<br>The efficacy through 9 months-PFS rate

Secondary Outcome Measures

Name	Time	Method

Related Trials