Combination of Brivanib With 5-Fluorouracil/Leucovorin (5FU/LV) and 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI)

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Camptothecin; Fluorouracil; Irinotecan; Leucovorin

Criteria

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