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| Sponsor: | Sarcoma Alliance for Research through Collaboration |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | Sarcoma Alliance for Research through Collaboration |
| ClinicalTrials.gov Identifier: | NCT00464620 |
Purpose
This study will examine the response rate and the 6-month progression-free survival rates of subjects with advanced sarcoma treated with dasatinib.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhabdomyosarcoma Malignant Peripheral Nerve Sheath Tumors Chondrosarcoma Sarcoma, Ewing's Sarcoma, Alveolar Soft Part Chordoma Epithelioid Sarcoma Giant Cell Tumor of Bone Hemangiopericytoma Gastrointestinal Stromal Tumor (GIST) |
Drug: Dasatinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
| Official Title: | A Phase II Trial of Dasatinib in Advanced Sarcomas |
| Estimated Enrollment: | 502 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Further details provided by SARC (Sarcoma Alliance for Research through Collaboration):
Treatment: Subjects take Dasatinib twice daily by mouth for 28 days per 28 day cycle.
Subjects will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. Subjects will undergo tumor imaging every 2 months (8 weeks) for the first 6 months and approximately every 3 months thereafter while on treatment.
A blood sample for collection of specimens with which to later study serum level of Dasatinib and effects on biomarkers of drug activity will be obtained approximately 2 to 4 weeks after the start of treatment.
Central collection of archival tumor with which to later study the frequency of expression and/or mutation of kinases inhibited by dasatinib will occur.
Subjects will be followed for approximately every 3 months until 2 years from registration and then approximately yearly until 5 years from registration.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Unresectable, recurrent, or metastatic histologically-confirmed soft tissue or bone sarcoma of one of the following subtypes:
Exclusion Criteria:
History of significant bleeding disorder unrelated to cancer, including:
Subjects currently taking one or more of the following drugs that are generally accepted to have a risk of causing Torsades de Pointes:
Contacts and Locations| United States, Arkansas | |
| Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| City of Hope | |
| Duarte, California, United States, 91010 | |
| Sarcoma Oncology Center | |
| Santa Monica, California, United States, 90403 | |
| Cedars-Sinai Outpatient Cancer Center | |
| Los Angeles, California, United States, 90048 | |
| United States, District of Columbia | |
| Washington Cancer Institute | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Georgia | |
| Winship Cancer Institute at Emory University | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Idaho | |
| Kootenai Cancer Center | |
| Coeur d'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Oncology Specialists | |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Nebraska | |
| Nebraska Methodist Hospital | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Pennsylvania | |
| Pennsylvania Oncology Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| MD Anderson | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Scott Schuetze, MD, PhD | University of Michigan |
More Information
| Responsible Party: | SARC ( Denise Reinke, MS, NP, President ) |
| Study ID Numbers: | SARC009 |
| Study First Received: | April 20, 2007 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00464620 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Dasatinib Rhabdomyosarcoma Malignant peripheral nerve sheath tumor Chondrosarcoma Ewing's Alveolar soft part sarcoma (ASPS) |
Chordoma Epithelioid sarcoma Giant cell tumor of bone Hemangiopericytoma/solitary fibrous tumor Gastrointestinal Stromal Tumor (GIST) |
|
Neoplasms, Muscle Tissue Molecular Mechanisms of Pharmacological Action Bone Neoplasms Gastrointestinal Diseases Neoplasms, Nerve Tissue Giant Cell Tumor of Bone Protein Kinase Inhibitors Chordoma Bone Diseases Neoplasms, Connective and Soft Tissue Sarcoma, Ewing's Giant Cell Tumors Neoplasms by Site Neuromuscular Diseases Musculoskeletal Diseases |
Dasatinib Neoplasms, Germ Cell and Embryonal Chondrosarcoma Neoplasms, Vascular Tissue Sarcoma, Alveolar Soft Part Nervous System Neoplasms Rhabdomyosarcoma Digestive System Neoplasms Neoplasms by Histologic Type Myosarcoma Nervous System Diseases Osteosarcoma Enzyme Inhibitors Hemangiopericytoma Pharmacologic Actions |