Conditions: Colorectal Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: BIBF1120 medium dose twice daily arm 2: Bevacizumab 5mg/kg once daily every other week

Interventions: intervention 1: BIBF 1120 intervention 2: BIBF 1120 intervention 3: mFolfox intervention 4: Bevacizumab intervention 5: mFolfox 6 intervention 6: bevacizumab
Intervention descriptions: intervention 1: BIBF 1120 100 and 150 mg capsules intervention 2: BIBF 1120 100 and 150 mg capsules intervention 3: standard i.v chemotherapy intervention 4: 100 mg/Kg solution , IV infusion intervention 5: IV standard chemotherapy intervention 6: 100 mg/4 ml solution

Protocol document: