Clinical trial · Interventional
Phase I/II Combination With Irinotecan- Erbitux
A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer
NCT00594984CI-TRIAL-00019706completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer (MCRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brivanib | Drug | — | UNRESOLVED |
| Brivanib Placebo | Drug | — | UNRESOLVED |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1 - Phase 1
- description
- Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
- interventionNames
- Drug: Cetuximab
- Drug: Irinotecan
- Drug: Brivanib
- Drug: Brivanib Placebo
- type
- PLACEBO_COMPARATOR
- label
- Arm 2 - Phase 2
- description
- Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
- interventionNames
- Drug: Cetuximab
- Drug: Irinotecan
- Drug: Brivanib
- Drug: Brivanib Placebo
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.