NCT00300027

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2006

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Last Updated

March 2, 2010

Status Verified

September 1, 2007

Enrollment Period

8 months

First QC Date

March 6, 2006

Last Update Submit

February 27, 2010

Conditions

Gastrointestinal Neoplasms

Keywords

Advanced Gastrointestinal Malignancies

Outcome Measures

Primary Outcomes (2)

  • Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)

  • Echocardiogram every 2 cycles (q 2 cycles)

Secondary Outcomes (4)

  • Tumor response (q 2 cycles)

  • PK parameters (during 1st cycle)

  • PD markers (weekly)

  • Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3)

Interventions

BMS-582664DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Brain metastasis
  • Thromboembolic disease
  • Cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Local Institution

Little Rock, Arkansas, United States

Location

Local Institution

Los Angeles, California, United States

Location

Local Institution

Washington D.C., District of Columbia, United States

Location

Local Institution

Iowa City, Iowa, United States

Location

Local Institution

Durham, North Carolina, United States

Location

Local Institution

Temple, Texas, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

brivanib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 6, 2006

First Posted

March 8, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2006

Last Updated

March 2, 2010

Record last verified: 2007-09

Locations

US(6)