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Phase I/II Combination With Irinotecan- Erbitux

NCT00594984 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2015-11-04

No results posted yet for this study

Summary

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

  • Metastatic Colorectal Cancer (MCRC)

Interventions

DRUG

Cetuximab

IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression

DRUG

Irinotecan

IV solution, IV, Q3W, 350 mg/m2, until progression

DRUG

Brivanib

Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression

DRUG

Brivanib

Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression

DRUG

Brivanib Placebo

Oral, tablet, QD, until progression

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Argentina
  • Denmark
  • Italy
  • South Korea
  • Spain
  • Sweden

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 NCT00594984 on ClinicalTrials.gov