Status:
COMPLETED
BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \>= 18 years
- Histologically proven colorectal adenocarcinoma
- No previous oxaliplatin based chemotherapy is allowed unless disease free survival after the end of chemotherapy \> = 12 months
- No previous therapy with VEGFR or EGFR inhibitors
- No prior systemic therapy for metastatic CRC
- No previous adjuvant therapy with fluoropyrimidines is allowed unless disease free survival after the end of chemotherapy \> 6 months
- ECOG performance status \< = 2
- Adequate hepatic, renal and bone marrow functions:
- No uncontrolled hypertension
- Signed and dated written informed consent prior to admission to the study
- Exclusion criteria:
- Treatment with any investigational drug within 28 days of trial onset.
- History of other malignancies in the last 5 years, in particular those that could affect compliance with the protocol or interpretation of results.
- 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,
- Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period.
- Significant cardiovascular diseases
- History of severe haemorrhagic or thromboembolic event in the past 12 months. Known inherited predisposition to bleeding or to thrombosis.
- Patient with brain metastases that are symptomatic and/or require therapy.
- Pregnancy or breast-feeding.
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00904839
Start Date
May 1 2009
End Date
January 1 2012
Last Update
February 4 2015
Active Locations (47)
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1
1199.51.32002 Boehringer Ingelheim Investigational Site
Bonheiden, Belgium
2
1199.51.32005 Boehringer Ingelheim Investigational Site
Brussels, Belgium
3
1199.51.32006 Boehringer Ingelheim Investigational Site
Brussels, Belgium
4
1199.51.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium