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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
Not Enrolling
Both
Tumors, Neoplasm Metastasis

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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 CenterIndianapolis, Indiana  46202
Premiere OncologySanta Monica, California  90404
University Of Wisconsin Comprehensive CenterMadison, Wisconsin  53792