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Phase I/II Combination With Irinotecan- Erbitux

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00594984
First received: January 7, 2008
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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)


Condition Intervention Phase
Metastatic Colorectal Cancer (MCRC)
Drug: Cetuximab
Drug: Irinotecan
Drug: Brivanib
Drug: Brivanib Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial [ Time Frame: PK C1D1-C2-D3, biomarker throughout the study ] [ Designated as safety issue: No ]
  • Safety and tolerability of interventions will be collected [ Time Frame: throughout the study on Part II ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects [ Time Frame: throughout the study on Part II ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: May 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 - Phase 1

Cetuximab + Irinotecan + Brivanib

OR

Cetuximab + Irinotecan + Brivanib Placebo

Drug: Cetuximab
IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
Other Names:
  • Erbitux
  • BMS-564717
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 Placebo
Oral, tablet, QD, until progression
Placebo Comparator: Arm 2 - Phase 2

Cetuximab + Irinotecan + Brivanib

OR

Cetuximab + Irinotecan + Brivanib Placebo

Drug: Cetuximab
IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
Other Names:
  • Erbitux
  • BMS-564717
Drug: Irinotecan
IV solution, IV, Q3W, 350 mg/m2, until progression
Drug: Brivanib
Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression
Drug: Brivanib Placebo
Oral, tablet, QD, until progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594984

Locations
United States, California
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Usc/Norris Comprehensive Cancer Center Hospital
Los Angeles, California, United States, 90033
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
Argentina
Local Institution
Buenos Aires, Argentina, C1426ANZ
Denmark
Local Institution
Odense C, Denmark, 5000
Italy
Local Institution
Meldola Fc, Italy, 47014
Local Institution
Milano, Italy, 20141
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 135-710
Spain
Local Institution
Madrid, Spain, 28050
Sweden
Local Institution
Stockholm, Sweden, 17176
Local Institution
Uppsala, Sweden, 75185
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00594984     History of Changes
Other Study ID Numbers: CA182-025, 2007-005097-31
Study First Received: January 7, 2008
Last Updated: September 24, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Cetuximab
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014