A Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies
The primary objective of the trial is to assess the efficacy of AP23573 in patients with
specified relapsed or refractory hematological malignancies by evaluating the response rates
as defined for the individual malignancy categories. Secondary objectives include
evaluating time to disease progression, progression-free survival and duration of response;
evaluating the pharmacokinetic and pharmacodynamic characteristics of AP23573; describing
health-related quality of life measurements; and exploring the safety and tolerability of
AP23573 at the specified dose level.
Protocol Outline: Open label, non-randomized parallel cohorts of five disease-specific
cohorts with a minimum of 21 patients per cohort. Each patient receives a fixed dose of
AP23573 administered intravenously (IV) over 30 minutes daily for five days (QDx5) to be
repeated every 2 weeks.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess efficacy of AP23573 in patients with relapsed or refractory hematologic malignancies.
Duration of study
Frank Haluska, M.D., Ph.D.
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Gabrail Cancer Center||Canton, Ohio 44718|
|The Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|University of Chicago Hospitals, Section of Hematology/Oncology||Chicago, Illinois 60637|
|Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place||St. Louis, Missouri 63110|
|New York Presbyterian Hospital, Weill College of Cornell University||New York, New York 10021|
|Morris Cancer Center - Duke University Medical Center, Adult Bone Marrow Transplant Clinic||Durham, North Carolina 27705|
|Jeane's Hospital of TUHS||Philadelphia, Pennsylvania 19111|