Safety Study of PT-523 in Cancer Patients to Treat Solid Tumors Including a Preliminary Assessment of Effectiveness
The purpose of this study is to determine the safety of a short intravenous infusion of PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of PT-523 in Patients With Solid Tumors|
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||December 2005|
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.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Isreal Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Joseph Paul Eder, M.D.||Dana-Farber Cancer Institute|