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

Phase 1TerminatedNCT00300027

Bristol-Myers Squibb50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastrointestinal Neoplasms

Interventions

BMS-582664DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (6)

Local Institution

Little Rock, Arkansas, United States

Local Institution

Los Angeles, California, United States

Local Institution

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

Local Institution

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

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

Echocardiogram every 2 cycles (q 2 cycles)

Secondary Outcomes

Tumor response (q 2 cycles)

PK parameters (during 1st cycle)

PD markers (weekly)

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

Data from ClinicalTrials.gov

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