A Phase I Study of PT-523 in Patients With Solid Tumors
The primary objectives of this study are 1) to evaluate the safety of a short intravenous
infusion of PT-523 when administered on days 1, 8, and 15 of a 28-day cycle to patients with
solid tumors who have failed curative or survival prolonging therapy or for whom no such
therapies exist; and 2) to establish the maximum tolerated dose (MTD) and identify the dose
limiting toxicities (DLT) of PT-523.
The secondary objectives of this study are to determine the pharmacokinetics and to evaluate
preliminary efficacy of PT-523.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Joseph Paul Eder, M.D.
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Beth Isreal Deaconess Medical Center||Boston, Massachusetts 02215|