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BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00207051
First received: September 12, 2005
Last updated: January 24, 2011
Last verified: March 2009
History of Changes
  Purpose

This is a phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in combination with full dose erbitux in patients with advanced colorectal cancer who have received no more than 2 prior regimens for metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
 Drug: Brivanib + Cetuximab
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Combination With Full Dose Erbitux in Patients With Advanced Gastrointestinal Malignancies Who Have Failed Prior Therapy

Resource links provided by NLM:

Drug Information available for: Cetuximab
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety assessment [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • dose limiting toxicity (DLT) [ Time Frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified ] [ Designated as safety issue: Yes ]
  • determination of maximum tolerated dose (MTD) [ Time Frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximu tolerated dose is identified ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy based on duration of response and time to progression based on assessment [ Time Frame: Measured every 8 weeks throughout the study ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Brivanib + Cetuximab
Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks
Other Names:
  • Erbitux
  • BMS-564717

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of advanced or metastatic (tumor has spread) gastrointestinal malignancy
  • Feeling well other than cancer diagnosis (ie lab work, no infection, etc)
  • Available tumor tissue sample from prior surgery
  • Measurable disease on scans
  • 4-6 weeks since prior therapy and recovered from the effects of prior therapy
  • Men and women, ages 18 and above
  • Women must not be pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207051

Locations
United States, California
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, District of Columbia
Georgetn Univ Lombardi Can Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
University Of Miami Miller School Of Medicine
Miami, Florida, United States, 33010
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8V 2C5
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Netherlands
Local Institution
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00207051     History of Changes
Other Study ID Numbers: CA182-003
Study First Received: September 12, 2005
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Advanced Gastrointestinal Malignancies

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013