Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Tumors, Neoplasm Metastasis
Both
Tumors, Neoplasm Metastasis
Trial Information
Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
Inclusion Criteria:
- Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
- No tumor spread to the brain
- Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
- Available tumor tissue sample from prior surgery
- 4-6 weeks since prior therapy and recovered from prior therapy
- Men and women, ages 18 and above
- Women must not be pregnant or breastfeeding
- Diagnosis of advanced or metastatic (tumor that has spread) colorectal,
hepatocellular (liver) or renal (kidney) cancer
- Measurable disease on scans (at least one)
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 assessment
Outcome Time Frame:
throughout the study
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA182-002
NCT ID:
NCT00207103
Start Date:
September 2004
Completion Date:
September 2008
Related Keywords:
- Tumors
- Neoplasm Metastasis
- Advanced metastatic or solid tumors
- Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Indiana University Med Center | Indianapolis, Indiana 46202 |
| Premiere Oncology | Santa Monica, California 90404 |
| University Of Wisconsin Comprehensive Center | Madison, Wisconsin 53792 |
