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| Sponsor: | Swiss Group for Clinical Cancer Research |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00568750 |
Purpose
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor |
Drug: dasatinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial |
| Estimated Enrollment: | 52 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease, including any of the following:
No concurrent medical condition (e.g., active autoimmune disease or uncontrolled diabetes) that would impair the ability of the patient to participate in the study (at the judgment of the investigator) or that may increase the risk of toxicity, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 7 days since prior and no concurrent potent CYP3A4 inhibitors, including any of the following:
At least 7 days since prior and no concurrent medications known to prolong the QT interval, including any of the following:
Contacts and Locations| Finland | |
| Biomedicum Helsinki | Recruiting |
| Helsinki, Finland, FI-00290 | |
| Contact: Contact Person 358-947-173-200 | |
| France | |
| Institut Bergonie | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Contact Person 33-5-56-33-3212 | |
| Hopital Edouard Herriot - Lyon | Recruiting |
| Lyon, France, 69437 | |
| Contact: Contact Person 33-4-72-11-7398 | |
| Centre Paul Strauss | Recruiting |
| Strasbourg, France, 67065 | |
| Contact: Contact Person 33-3-88-252-401 | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, F-94805 | |
| Contact: Contact Person 33-1-42-114-316 | |
| Germany | |
| Universitaetsklinikum Essen | Recruiting |
| Essen, Germany, D-45122 | |
| Contact: Contact Person 49-201-723-85-011 | |
| Switzerland | |
| Kantonsspital Baden | Recruiting |
| Baden, Switzerland, CH-5404 | |
| Contact: Contact Person 41-56-486-2511 | |
| Saint Claraspital AG | Recruiting |
| Basel, Switzerland, CH-4016 | |
| Contact: Contact Person 41-61-685-8325 | |
| Universitaetsspital-Basel | Recruiting |
| Basel, Switzerland, CH-4031 | |
| Contact: Contact Person 41-61-265-5714 | |
| Kantonsspital Bruderholz | Recruiting |
| Bruderholz, Switzerland, CH-4101 | |
| Contact: Contact Person 41-61-436-3636 | |
| Kantonsspital Graubuenden | Recruiting |
| Chur, Switzerland, CH-7000 | |
| Contact: Contact Person 41-21-314-0150 | |
| Hopital Cantonal Universitaire de Geneve | Recruiting |
| Geneva, Switzerland, CH-1211 | |
| Contact: Contact Person 41-22-372-7744 | |
| Centre Hospitalier Universitaire Vaudois | Recruiting |
| Lausanne, Switzerland, CH-1011 | |
| Contact: Contact Person 41-21-314-0150 | |
| Kantonsspital Liestal | Recruiting |
| Liestal, Switzerland, CH-4410 | |
| Contact: Contact Person 41-61-925-2715 | |
| Kantonsspital - St. Gallen | Recruiting |
| St. Gallen, Switzerland, CH-9007 | |
| Contact: Contact Person 41-71-494-3569 | |
| City Hospital Triemli | Recruiting |
| Zurich, Switzerland, CH-8063 | |
| Contact: Contact Person 41-44-466-1273 | |
| UniversitaetsSpital Zuerich | Recruiting |
| Zurich, Switzerland, CH-8091 | |
| Contact: Contact Person 41-44-255-2244 | |
| Onkozentrum - Klinik im Park | Recruiting |
| Zurich, Switzerland, 8002 | |
| Contact: Contact Person 41-43-344-3333 | |
| Study Chair: | Michael Montemurro, MD | Centre Hospitalier Universitaire Vaudois |
More Information
| ClinicalTrials.gov Identifier: | NCT00568750 History of Changes |
| Other Study ID Numbers: | CDR0000577496, SWS-SAKK-56/07, EU-20789, EUDRACT-2007-002047-24 |
| Study First Received: | December 5, 2007 |
| Last Updated: | November 3, 2009 |
| Health Authority: | Unspecified |
|
gastrointestinal stromal tumor |
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |