At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 128 enrolled
Drug / intervention
BIBF 1120 +5 moredrug
Likely dose
BIBF 1120 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I-II Study of BIBF 1120 and FOLFOX Compared to Bevacizumab and FOLFOX in First Line Metastatic Colorectal Cancer Patients
In Brief
A Phase 2 clinical trial evaluating BIBF 1120, mFolfox, and 3 other interventions for Colorectal Neoplasms. Completed, enrolled 128 participants across 47 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasms
CountriesBelgium, France, Germany, Italy, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedMay 2009
Primary CompletionJan 2012
TodayJul 2026
First PostedMay 20, 2009
Enrollment StartMay 1, 2009
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.1 years ago
Interventions
BIBF 1120drug
BIBF 1120 100 and 150 mg capsules
BIBF 1120drug
BIBF 1120 100 and 150 mg capsules
mFolfoxdrug
standard i.v chemotherapy
Bevacizumabdrug
100 mg/Kg solution , IV infusion
mFolfox 6drug
IV standard chemotherapy
bevacizumabdrug
100 mg/4 ml solution