BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer

A Phase I-II Study of BIBF 1120 and FOLFOX Compared to Bevacizumab and FOLFOX in First Line Metastatic Colorectal Cancer Patients

The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.

Inclusion criteria:

1. Age >= 18 years
2. Histologically proven colorectal adenocarcinoma
3. No previous oxaliplatin based chemotherapy is allowed unless disease free survival after the end of chemotherapy > = 12 months
4. No previous therapy with VEGFR or EGFR inhibitors
5. No prior systemic therapy for metastatic CRC
6. No previous adjuvant therapy with fluoropyrimidines is allowed unless disease free survival after the end of chemotherapy > 6 months
7. ECOG performance status < = 2
8. Adequate hepatic, renal and bone marrow functions:
9. No uncontrolled hypertension
10. Signed and dated written informed consent prior to admission to the study

Exclusion criteria:

1. Treatment with any investigational drug within 28 days of trial onset.
2. History of other malignancies in the last 5 years, in particular those that could affect compliance with the protocol or interpretation of results.
3. Serious concomitant disease, especially those affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug,
4. Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period.
5. Significant cardiovascular diseases
6. History of severe haemorrhagic or thromboembolic event in the past 12 months. Known inherited predisposition to bleeding or to thrombosis.
7. Patient with brain metastases that are symptomatic and/or require therapy.
8. Pregnancy or breast-feeding.