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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00207051
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 25, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: Brivanib + Cetuximab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety assessment [ Time Frame: throughout the study ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. Efficacy based on duration of response and time to progression based on assessment [ Time Frame: Measured every 8 weeks throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00207051

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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
Local Institution
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00207051     History of Changes
Other Study ID Numbers: CA182-003
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: March 2009
Keywords provided by Bristol-Myers Squibb:
Advanced Gastrointestinal Malignancies
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antineoplastic Agents