Phase I Dose Escalation Study to Evaluate the Safety of T138067-Sodium in Patients With Advanced Refractory Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of T138067 sodium that can be given to
patients with advanced refractory cancer on a 28-day schedule and establish a dose for
further study. II. Evaluate the safety and dose limiting toxicity of T138067 sodium in these
patients. III. Determine the pharmacokinetic parameters after a single intravenous dose of
this agent in these patients. IV. Obtain safety data and preliminary efficacy information
after repetition of single doses of T138067 sodium in these patients.
OUTLINE: This is an open label, dose escalation study. Patients receive T138067 sodium by IV
over 3 hours. Patients may be retreated every 4 weeks for up to 6 courses (6 months total)
in the absence of disease progression or dose limiting toxicity (DLT). At least 3 patients
are treated at each dose level in the absence of DLT. The maximum tolerated dose is defined
as the dose level where 2 of 3-6 patients experience DLT.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into this study.
Primary Purpose: Treatment
David R. Spriggs, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|