Clinical trial · Interventional
Combination of Brivanib With 5-Fluorouracil/Leucovorin (5FU/LV) and 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI)
A Phase Ib Multiple Ascending Dose Study to Evaluate the Safety of Brivanib in Combination With 5-Fluorouracil/Leucovorin (5FU/LV) and Brivanib in Combination With 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI) in Subjects With Advanced or Metastatic Gastrointestinal Malignancies
NCT01046864CI-TRIAL-00015626completedPhase 1ClinicalTrials.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)
The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when combined with standard dose 5FU/LV and FOLFIRI.
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 |
|---|---|---|---|
| Gastro-Intestinal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Brivanib | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: 5-FU
- Drug: Leucovorin
- Drug: Brivanib
- type
- EXPERIMENTAL
- label
- Arm 2
- interventionNames
- Drug: 5-FU
- Drug: Leucovorin
- Drug: Irinotecan
- Drug: Brivanib
- type
- EXPERIMENTAL
- label
- Arm 3
- description
- Japanese Population
- interventionNames
- Drug: 5-FU
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological/cytological confirmed diagnosis of Gastrointestinal malignancy, except pancreatic cancer * Eligible for 5FU/LV or FOLFIRI chemotherapy * ECOG 0-1 * Able to swallow and tolerate tablets * Life expectancy of 3 months Exclusion Criteria: * Unwilling to use acceptable method to avoid pregnancy of partner/self for the entire study period and up to 4 weeks after last dose * Women who are pregnant or breastfeeding * Pancreatic cancer * Known brain metastasis, evidence of leptomeningeal disease * History of thrombo-embolic disease * Hemorrhage/bleeding events * Uncontrolled or significant cardiovascular disease * Any 3 or more of the following risk factors: arterial thrombosis , smoking, hypercholesterolemia, hypertension, obesity (BMS\>30) and diabetes * Pre-existing thyroid abnormality, not maintained with medication * QTC (Fridericia) \>450 msec on two consecutive ECG's * Subjects with concomitant second malignancies ( except adequately treated non-melanoma skin, in situ carcinoma of bladder, cervix or breast, early prostate cancer) * Any major surgery within 4 weeks of study drug administration * Increased levels of both D-Dimer and Prothrombin fragment 1 +2 * Arm B and C only-positive UGT1A1 genotype of TA7/TA7 * History of allergy of brivanib or drug class * History of severe reactions to fluoropyrimidine therapy or irinotecan * Prior therapy with brivanib
References
Publications (0)
Data not yet available
No reference posted for this study.