Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Ariad Pharmaceuticals |
---|---|
Information provided by: | Ariad Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00093080 |
The purpose of this study is to assess the efficacy of AP23573 in patients with advanced sarcoma when administered once daily for 5 consecutive days (QDx5) every two weeks.
Condition | Intervention | Phase |
---|---|---|
Leiomyosarcoma Liposarcoma Osteosarcoma Sarcoma, Soft Tissue Metastases |
Drug: ridaforolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Advanced Sarcoma |
Enrollment: | 212 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | December 2009 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
12.5 mg of AP23573 is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
|
Drug: ridaforolimus
12.5 mg of AP23573 is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
|
The primary objective of this study is to assess the efficacy of AP23573 in patients with advanced sarcoma when administered once daily for 5 consecutive days (QDx5) every two weeks. The secondary objectives are to assess the safety & tolerability of this study drug regimen; to evaluate secondary efficacy endpoints, such as time to tumor progression, progression-free survival and duration of response; and to examine AP23573 blood levels and experimental parameters that may predict or indicate response to mTOR inhibition, such as effects on plasma VEGF levels and markers of tumoral PI3K/mTOR-pathway activity.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Sant P. Chawla, MD, Inc. | |
Santa Monica, California, United States, 90403 | |
USC/Norris Comprehensive Cancer Center, LAC+USC Medical Center | |
Los Angeles, California, United States, 90033 | |
City of Hope National Medical Center | |
Duarte, California, United States, 91010 | |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Pennsylvania | |
Pennsylvania Oncology Hematology Associates | |
Philadelphia, Pennsylvania, United States, 19106 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Texas | |
Cancer Therapy and Research Center, Institute for Drug Development | |
San Antonio, Texas, United States, 78229 | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States, 75246 | |
France | |
Centre Leon-Berard | |
Lyon, France | |
Institut Gustave Roussy | |
Cedex, France, 94805 |
Study Director: | Frank Haluska, M.D. | Ariad Pharmaceuticals |
Responsible Party: | Ariad Pharmaceuticals, Inc. ( Frank Haluska, M.D. ) |
Study ID Numbers: | AP23573-04-202, EudraCT #:2004-002231-92 |
Study First Received: | September 30, 2004 |
Last Updated: | May 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00093080 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic and/or unresectable soft tissue or |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Liposarcoma Leiomyosarcoma |
Neoplasm Metastasis Sarcoma Osteogenic Sarcoma Osteosarcoma |
Neoplasms, Muscle Tissue Neoplasms by Histologic Type Leiomyosarcoma Osteosarcoma Neoplasms, Connective and Soft Tissue Liposarcoma Neoplasms |
Neoplastic Processes Pathologic Processes Neoplasms, Bone Tissue Neoplasm Metastasis Sarcoma Neoplasms, Connective Tissue Neoplasms, Adipose Tissue |