Breast Cancer Clinical Trial
Official title:
A Phase I Study Of SU006668 Via Twice Daily Oral Administration Under Fed Conditions In Patients With Advanced Malignancies
RATIONALE: Drugs such as SU006668 may stop the growth of solid tumors by stopping blood flow
to the tumor.
PURPOSE: Phase I trial to study the effectiveness of SU006668 in treating patients who have
advanced solid tumors.
OBJECTIVES: I. Determine the maximum tolerated dose of SU006668 in patients with advanced
solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III.
Determine the objective response of patients treated with this drug. IV. Determine the toxic
effects of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients receive oral SU006668 twice daily.
Treatment repeats every 28 days in the absence of disease progression or unacceptable
toxicity. Cohorts of 6 to 12 patients receive escalating doses of SU006668 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 6 or 4 of 12 patients experience dose-limiting toxicity. Patients are followed
at 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
;
Primary Purpose: Treatment
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