Phase I/II Combination With Irinotecan- Erbitux
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00594984
First received: January 7, 2008
Last updated: March 28, 2013
Last verified: February 2013
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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:
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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594984
Locations
| United States, Kentucky | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, New Jersey | |
| The Cancer Institute Of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Nyu Clinical Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, Texas | |
| South Texas Oncology And Hematology, P.A. | |
| San Antonio, Texas, United States, 78207 | |
| Scott And White Memorial Hosp | |
| Temple, Texas, United States, 76508 | |
| United States, West Virginia | |
| West Virginia University | |
| Morgantown, West Virginia, United States, 26506 | |
| Italy | |
| Local Institution | |
| Bari, Italy, 70126 | |
| Spain | |
| Local Institution | |
| Madrid, Spain, 28050 | |
| Local Institution | |
| Madrid, Spain, 28041 | |
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: | March 28, 2013 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Irinotecan |
Cetuximab Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013