Skip to main content
OpenTrials
Completed

NCT Number: NCT00594984

Phase I/II Combination With Irinotecan- Erbitux

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Colorectal Cancer (mCRC) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy proven MCRC
  • Prior irinotecan allowed
  • Prior Erbitux allowed

Exclusion criteria

  • No prior brivanib
  • No prior combination of irinotecan with Erbitux
  • No secondary malignancies
  • No anti-coagulation therapy
  • No prior history of blood clots requiring anti-coagulation

Treatment and study plan

Cetuximab

Drug

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

Other names: Erbitux, BMS-564717

Irinotecan

Drug

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

Brivanib

Drug

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

Brivanib Placebo

Drug

Oral, tablet, QD, until progression

Primary outcomes

  1. Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial

    Time frame: PK C1D1-C2-D3, biomarker throughout the study

  2. Safety and tolerability of interventions will be collected

    Time frame: throughout the study on Part II

Secondary outcomes

  1. Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects

    Time frame: throughout the study on Part II

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 16, 2008
Registry last updated
Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.