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

Gastrointestinal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00300027
• Other study ID #: CA182-007
• Status: Terminated
• Phase: Phase 1
• First received: March 6, 2006
• Last updated: February 27, 2010
• Start date: April 2006

Study information

• Verified date: September 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

Drug:
• BMS-582664

Locations

Country	Name	City	State
United States	Local Institution	Durham	North Carolina
United States	Local Institution	Iowa City	Iowa
United States	Local Institution	Little Rock	Arkansas
United States	Local Institution	Los Angeles	California
United States	Local Institution	Temple	Texas
United States	Local Institution	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
Primary	Echocardiogram every 2 cycles (q 2 cycles)
Secondary	Tumor response (q 2 cycles)
Secondary	PK parameters (during 1st cycle)
Secondary	PD markers (weekly)
Secondary	Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3)

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm