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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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Gastrointestinal Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Authority:

United States: Food and Drug Administration

Study ID:

CA182-007

NCT ID:

NCT00300027

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Gastrointestinal Neoplasms
  • Advanced Gastrointestinal Malignancies
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms

Name

Location
Local Institution Corona, California  
Local Institution Washington, District of Columbia  
Local Institution Wilmington, North Carolina  
Local Institution Austin, Texas  
Local Institution Little Rock, Arkansas  
Local Institution Iowa City, Iowa