A Phase I Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies
I. Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in
patients with advanced malignancies.
II. Determine the qualitative and quantitative toxic effects of this regimen in these
III. Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
IV. Determine the antitumor effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to prior therapy
(heavily pretreated vs minimally pretreated).
Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, additional patients
are treated at that dose level. Patients treated at the MTD receive treatment once weekly on
weeks 1-3 of each 4-week course.
Patients are followed within 1 month.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Chris H. Takimoto, MD, PhD, FACP
University of Texas Health Science Center at San Antonio
United States: Food and Drug Administration
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Veterans Affairs Medical Center - San Antonio (Murphy)||San Antonio, Texas 78284|
|Cancer Therapy and Research Center||San Antonio, Texas 78229|