Third Phase I and Pharmacokinetic Study Of FB-642 Administered Orally To Patients With Advanced Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose of carbendazim in patients with advanced
solid tumors or lymphoma. II. Determine the qualitative and quantitative toxic effects of
this drug in these patients. III. Determine the pharmacokinetics of this drug in these
patients. IV. Determine the recommended phase II dose of this drug. V. Determine any
antitumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral carbendazim 2-3
times daily 5 days a week for 3-4 weeks. Treatment repeats every 4 weeks in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
doses of carbendazim until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity. Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 30-60 patients will be accrued for this study.
Primary Purpose: Treatment
Lee S. Rosen, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government