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Sponsored by: |
Ariad Pharmaceuticals |
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Information provided by: | Ariad Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00086125 |
The purpose of this phase II study is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies.
Condition | Intervention | Phase |
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Hematologic Malignancies Leukemia Myelodysplastic Syndromes Myeloid Metaplasia Lymphoma |
Drug: AP23573 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies |
Enrollment: | 55 |
Study Start Date: | June 2004 |
Study Completion Date: | June 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks
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Drug: AP23573
AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Patients must meet each of the following criteria to be eligible for participation in the trial):
Exclusion Criteria (Patients meeting any of the following criteria are ineligible for participation in the study):
Drugs and Other Treatments to be Excluded (The following drugs and other treatments are not permitted for patients enrolling in the study, either during or within two weeks prior to the first dose of AP23573, unless otherwise specified):
United States, Illinois | |
University of Chicago Hospitals, Section of Hematology/Oncology | |
Chicago, Illinois, United States, 60637 | |
United States, Missouri | |
Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place | |
St. Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
The Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08903 | |
United States, New York | |
New York Presbyterian Hospital, Weill College of Cornell University | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Morris Cancer Center - Duke University Medical Center, Adult Bone Marrow Transplant Clinic | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
Gabrail Cancer Center | |
Canton, Ohio, United States, 44718 | |
United States, Pennsylvania | |
Jeane's Hospital of TUHS | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Director: | Frank Haluska, M.D., Ph.D. | Ariad Pharmaceuticals |
Responsible Party: | ARIAD Pharmaceuticals, Inc ( Frank Haluska, M.D., Ph.D., Vice President, Clinical Research ) |
Study ID Numbers: | AP23573-04-201 |
Study First Received: | June 24, 2004 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00086125 |
Health Authority: | United States: Food and Drug Administration |
Relapsed or refractory hematologic malignancies |
Myelodysplastic syndromes Myelofibrosis Immunoproliferative Disorders Precancerous Conditions Hematologic Neoplasms Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Myeloproliferative Disorders |
Myeloid Metaplasia Myelofibrosis-osteosclerosis Leukemia Lymphatic Diseases Preleukemia Metaplasia Bone Marrow Diseases Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Site Disease Pathologic Processes |
Neoplasms by Histologic Type Immune System Diseases Syndrome Splenic Diseases |