search
Back to results

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

Primary Purpose

Gastrointestinal Neoplasms

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-582664
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms focused on measuring Advanced Gastrointestinal Malignancies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

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)

Full Information

First Posted
March 6, 2006
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT00300027
Brief Title
Study of BMS-582664 in Combination With Either FOLFIRI or FOLFOX for Gastrointestinal (GI) Malignancies
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 Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Terminated
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms
Keywords
Advanced Gastrointestinal Malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BMS-582664
Primary Outcome Measure Information:
Title
Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
Title
Echocardiogram every 2 cycles (q 2 cycles)
Secondary Outcome Measure Information:
Title
Tumor response (q 2 cycles)
Title
PK parameters (during 1st cycle)
Title
PD markers (weekly)
Title
Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Local Institution
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Local Institution
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Local Institution
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Local Institution
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Temple
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs