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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

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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 InstitutionCorona, California  
Local InstitutionWashington, District of Columbia  
Local InstitutionWilmington, North Carolina  
Local InstitutionAustin, Texas  
Local InstitutionLittle Rock, Arkansas  
Local InstitutionIowa City, Iowa