Spots Global Cancer Trial Database for Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)
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Trial Identification
Brief Title: Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)
Official Title: A Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies
Study ID: NCT00086125
Interventions
Study Description
Brief Summary: The purpose of this phase II study is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Chicago Hospitals, Section of Hematology/Oncology, Chicago, Illinois, United States
Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place, St. Louis, Missouri, United States
The Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New York Presbyterian Hospital, Weill College of Cornell University, New York, New York, United States
Morris Cancer Center - Duke University Medical Center, Adult Bone Marrow Transplant Clinic, Durham, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
Jeane's Hospital of TUHS, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Frank Haluska, M.D., Ph.D.
Affiliation: Ariad Pharmaceuticals
Role: STUDY_DIRECTOR
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