drugset / Trial / NCT01046864

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

NCT01046864

Phase 1 Completed 49 enrolled Bristol-Myers Squibb
Non-randomizedFactorialOpen-labelTreatment

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.

Timeline

Start
2010-02
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Brivanib Small molecule 400 mg Oral
Subject Brivanib Small molecule 600 mg Oral
Subject Brivanib Small molecule 800 mg Oral
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous