Study of BMS-582664 in Combination With Either FOLFIRI or FOLFOX for Gastrointestinal (GI) Malignancies

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00300027
First received: March 6, 2006
Last updated: February 27, 2010
Last verified: September 2007
  Purpose

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 Intervention Phase
Gastrointestinal Neoplasms
Drug: BMS-582664
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: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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

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

Estimated Enrollment: 50
Study Start Date: April 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00300027

Locations
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00300027     History of Changes
Other Study ID Numbers: CA182-007
Study First Received: March 6, 2006
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Advanced Gastrointestinal Malignancies

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

ClinicalTrials.gov processed this record on August 21, 2014