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

NCT01046864 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2014-09-16

No results posted yet for this study

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.

Conditions

  • Gastro-Intestinal Cancer

Interventions

DRUG

5-FU

IV solution, IV bolus over 2-4 minutes, 400 mg/m², Every 14 days, Until disease progression/toxicity

DRUG

Leucovorin

IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity

DRUG

5-FU

IV solution, IV infusion over 46 hours, 2400 mg/m², Every 14 days, Until disease progression/toxicity

DRUG

Irinotecan

IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity

DRUG

Brivanib

Tablets, Oral, 400 - 800 mg, once daily, Until disease progression/toxicity

DRUG

Brivanib

Tablets, Oral, 600 - 800 mg, once daily, Until disease progression/toxicity

DRUG

Brivanib

Tablets, Oral, 800 mg, once daily, Until disease progression/toxicity

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States
  • Canada
  • France

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01046864 on ClinicalTrials.gov