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Sponsors and Collaborators: |
Sarcoma Alliance for Research through Collaboration Bristol-Myers Squibb |
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Information provided by: | Sarcoma Alliance for Research through Collaboration |
ClinicalTrials.gov Identifier: | NCT00464620 |
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 |
---|---|---|
MFH/Pleomorphic Undifferentiated Sarcoma Rhabdomyosarcoma Malignant Peripheral Nerve Sheath Tumors Osteosarcoma 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 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.
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:
Contact: Denise Reinke, MS, NP, President | 734-930-7600 | sarc@sarctrials.org |
Contact: Kathleen Granlund | 734-930-7607 | kegranlund@sarctrials.org |
United States, Arkansas | |
Arkansas Children's Hospital | Recruiting |
Little Rock, Arkansas, United States, 72202 | |
Contact: Bryce Warren WarrenBryceA@uams.edu | |
Principal Investigator: Kimo Stine | |
United States, California | |
Stanford University | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Maria Ahern 650-725-6413 mahern@stanford.edu | |
Principal Investigator: Kristen Ganjoo, MD | |
City of Hope | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Neeti Arora 626-256-4673 ext 63019 NArora@coh.org | |
Principal Investigator: Warren Chow, MD | |
Sarcoma Oncology Center | Recruiting |
Santa Monica, California, United States, 90403 | |
Contact: Viky Chua 310-552-9999 vikychua@aol.com | |
Principal Investigator: Sant Chawla | |
Cedars-Sinai Outpatient Cancer Center | Recruiting |
Los Angeles, California, United States, 90048 | |
Contact: Chi Vu 310-423-2133 CVu@csocc.com | |
Principal Investigator: Charles Forscher, MD | |
United States, District of Columbia | |
Washington Cancer Institute | Recruiting |
Washington, District of Columbia, United States, 20010 | |
Contact: Christina Sheeran 202-877-5371 Christina.M.Sheeran@medstar.net | |
Principal Investigator: Dennis A Priebat, MD | |
United States, Georgia | |
Winship Cancer Institute at Emory University | Recruiting |
Atlanta, Georgia, United States, 30308 | |
Contact: Ernest Evans 404-686-1855 ernest.evans@emoryhealthcare.org | |
Principal Investigator: Gina D'Amato, MD | |
United States, Idaho | |
Kootenai Cancer Center | Recruiting |
Coeur d'Alene, Idaho, United States, 83814 | |
Contact: Sheryl Golden 208-666-2093 sgolden@kmc.org | |
Principal Investigator: Brian Samuels, MD | |
United States, Illinois | |
Oncology Specialists | Recruiting |
Park Ridge, Illinois, United States, 60068 | |
Contact: Kathy Tolzien 847-268-8569 ktolzien@oncmed.net | |
Principal Investigator: Pamela Kaiser, MD | |
United States, Indiana | |
Indiana University Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Kristen Potter, MS 317-278-6616 krpotter@iupui.edu | |
Principal Investigator: Daniel Rushing, MD | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Melanie Frees, RN, BSN, CCRC 319-356-1228 melanie-frees@uiowa.edu | |
Principal Investigator: Mohammed Milhem, MD | |
United States, Maryland | |
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Adult Oncology 410-955-8804 | |
Contact: Pediatric Oncology 410-955-8751 | |
Principal Investigator: David Loeb, MD, PhD | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Anthony Thomas 617-643-5411 athomas2@partners.org | |
Principal Investigator: Edwin Choy, MD | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Sarah Solomon 617-582-7503 ssolomon1@partners.org | |
Principal Investigator: James Butrynski, MD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Gino Metko 734-647-2095 ginom@med.umich.edu | |
Principal Investigator: Scott Schuetze, MD, PhD | |
United States, Nebraska | |
Nebraska Methodist Hospital | Recruiting |
Omaha, Nebraska, United States, 68114 | |
Contact: Gladys Pierce 402-354-5129 Gladys.Pierce@nmhs.org | |
Principal Investigator: Kirsten Leu, MD | |
United States, Pennsylvania | |
Pennsylvania Oncology Hematology Associates | Recruiting |
Philadelphia, Pennsylvania, United States, 19106 | |
Contact: Deb Riordan, RN, BS 215-829-6712 debbieriordan@pennoncology.com | |
Principal Investigator: Arthur Staddon, MD | |
Fox Chase Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19111 | |
Contact: Monica Davey 215-728-5534 M_Davey@fccc.edu | |
Principal Investigator: Margaret von Mehren, MD | |
University of Pittsburgh Cancer Institute | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Lynne Frydrych 412-623-4036 frydrychlm2@upmc.edu | |
Principal Investigator: Hussein Tawbi, MD, MSc | |
United States, Texas | |
MD Anderson | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Joanne Gigstad 713-563-0510 jgigstad@mdanderson.org | |
Principal Investigator: Shreyas Patel, MD |
Principal Investigator: | Scott Schuetze, MD, PhD | University of Michigan |
Responsible Party: | SARC ( Denise Reinke, MS, NP, President ) |
Study ID Numbers: | SARC009 |
Study First Received: | April 20, 2007 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00464620 |
Health Authority: | United States: Institutional Review Board |
Dasatinib MFH/pleomorphic undifferentiated sarcoma Rhabdomyosarcoma Malignant peripheral nerve sheath tumor Osteosarcoma (skeletal or extra osseous) Chondrosarcoma Ewing's |
Alveolar soft part sarcoma (ASPS) Chordoma Epithelioid sarcoma Giant cell tumor of bone Hemangiopericytoma/solitary fibrous tumor Gastrointestinal Stromal Tumor (GIST) |
Bone Neoplasms Gastrointestinal Diseases Epithelioid sarcoma Malignant mesenchymal tumor Bone neoplasms Alveolar soft part sarcoma Giant Cell Tumor of Bone Osteogenic sarcoma Chordoma Bone Diseases Soft tissue sarcomas Neoplasms, Connective and Soft Tissue Ewing's sarcoma Giant Cell Tumors Sarcoma, Ewing's |
Nerve sheath neoplasm Musculoskeletal Diseases Neuromuscular Diseases Dasatinib Neoplasms, Germ Cell and Embryonal Chondrosarcoma Sarcoma, Alveolar Soft Part Embryonal sarcoma Nervous System Neoplasms Rhabdomyosarcoma Digestive System Neoplasms Osteosarcoma Hemangiopericytoma Digestive System Diseases Peripheral Nervous System Diseases |
Neoplasms, Muscle Tissue Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Myosarcoma Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Vascular Tissue Neoplasms, Connective Tissue |