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Phase I Study of BMS-184476 in Patients With Advanced Malignancies (NCT00003705)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of BMS-184476 in treating patients who have advanced solid tumors.
  • Drug: BMS-184476
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, recommended phase II dose, and safety of BMS-184476 in patients with advanced solid tumors. II. Determine the pharmacokinetic profile of BMS-184476 and its metabolites in these patients. III. Determine preliminary evidence of antitumor activity of BMS-184476 in these patients.

    OUTLINE: This is an open label, dose escalation study. Patients receive BMS-184476 IV over 1 hour. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. In the second part of the study, patients receive BMS-184476 IV over 1 hour weekly. Cohorts of 3-6 patients are treated at escalating doses of BMS-184476. The maximum tolerated dose is defined as the dose at which fewer than 2 of 6 patients experience dose limiting toxicity. Patients are followed every 4 weeks until toxicity is resolved.

    PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 12-18 months.

    2 locations

    United States (2)
    • Brooke Army Medical Center
      Not specified
      Fort Sam Houston, Texas, United States, 78234
    • San Antonio Cancer Institute
      Not specified
      San Antonio, Texas, United States, 78229-3264
    31 October, 1997
    22 July, 2008
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