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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00300027

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Fluorouracil Oxaliplatin Brivanib alaninate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
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

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

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

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

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CA182-007
Study First Received:	March 6, 2006
Last Updated:	September 28, 2007
ClinicalTrials.gov Identifier:	NCT00300027
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Advanced Gastrointestinal Malignancies

Study placed in the following topic categories:

Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil

Irinotecan
Neoplasm Metastasis
Leucovorin
Gastrointestinal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009