Study of BMS-582664 in Combination With Either FOLFIRI or FOLFOX for Gastrointestinal (GI) 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: NCT00300027
Recruitment Status : Terminated
First Posted : March 8, 2006
Last Update Posted : March 2, 2010
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced gastrointestinal malignancies and to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.

Condition or disease Intervention/treatment Phase
Gastrointestinal Neoplasms Drug: BMS-582664 Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Combination With 5-Fluorouracil/Leucovorin and Irinotecan or Oxaliplatin for Patients With Advanced or Metastatic Cancer
Study Start Date : April 2006
Actual Primary Completion Date : December 2006

Primary Outcome Measures :
  1. Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
  2. Echocardiogram every 2 cycles (q 2 cycles)

Secondary Outcome Measures :
  1. Tumor response (q 2 cycles)
  2. PK parameters (during 1st cycle)
  3. PD markers (weekly)
  4. Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Good performance status
  • Advanced colorectal, pancreatic, esophageal or gastric cancer
  • Tissue for analyses
  • Adequate bone marrow, hepatic, renal function
  • 4-6 weeks since prior therapy
  • Adequate protection for women of child bearing potential (WOCBP)

Exclusion Criteria:

  • Brain metastasis
  • Thromboembolic disease
  • Cardiovascular disease

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): NCT00300027

United States, Arkansas
Local Institution
Little Rock, Arkansas, United States
United States, California
Local Institution
Los Angeles, California, United States
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States
United States, Iowa
Local Institution
Iowa City, Iowa, United States
United States, North Carolina
Local Institution
Durham, North Carolina, United States
United States, Texas
Local Institution
Temple, Texas, United States
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information: Identifier: NCT00300027     History of Changes
Other Study ID Numbers: CA182-007
First Posted: March 8, 2006    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: September 2007

Keywords provided by Bristol-Myers Squibb:
Advanced Gastrointestinal Malignancies

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases