Metastatic Colorectal Cancer (MCRC)
Conditions
Brief summary
Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC) Part 2: To compare median duration of progression free survival (PFS)
Interventions
DRUGCetuximab
IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
DRUGIrinotecan
IV solution, IV, Q3W, 350 mg/m2, until progression
DRUGBrivanib
Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression
DRUGBrivanib Placebo
Oral, tablet, QD, until progression
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy proven MCRC * Prior irinotecan allowed * Prior Erbitux allowed
Exclusion criteria
* No prior brivanib * No prior combination of irinotecan with Erbitux * No secondary malignancies * No anti-coagulation therapy * No prior history of blood clots requiring anti-coagulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial | PK C1D1-C2-D3, biomarker throughout the study |
| Safety and tolerability of interventions will be collected | throughout the study on Part II |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects | throughout the study on Part II |
Countries
Argentina, Denmark, Italy, South Korea, Spain, Sweden, United States
Outcome results
None listed