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Sponsors and Collaborators: |
Weill Medical College of Cornell University Bristol-Myers Squibb |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00538980 |
The purpose for conducting this research study is to determine the feasibility of using dasatinib as a treatment for polycythemia vera and to determine the optimum treatment regimen.
Condition | Intervention | Phase |
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Polycythemia Vera |
Drug: Dasatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | The Use of Dasatinib (SPRYCEL) in Treating Patients With Polycythemia Vera (PV): A Phase II, Non-Randomized Study |
Estimated Enrollment: | 24 |
Study Start Date: | April 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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All patients: Experimental
Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
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Drug: Dasatinib
Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate Organ Function
Women of childbearing potential (WOCBP) must have:
Exclusion Criteria:
Concurrent medical condition which may increase the risk of toxicity, including:
Cardiac Symptoms, consider the following:
History of significant bleeding disorder unrelated to cancer, including:
Concomitant Medications, consider the following prohibitions:
Women:
United States, New York | |
Weill Cornell Medical College - New York Presbyterian Hospital | Recruiting |
New York, New York, United States, 10021 | |
Contact: Fernando Adriano, R.N. 212-746-4882 fea2004@med.cornell.edu | |
Principal Investigator: Richard T Silver, M.D. |
Principal Investigator: | Richard T Slver, M.D. | Weill Cornell Medical College |
Responsible Party: | Weill Medical College of Cornell University ( Richard Silver, M.D. / Professor of Medicine ) |
Study ID Numbers: | CA180-104, 0701008940 |
Study First Received: | October 2, 2007 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00538980 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Polycythemia Vera PV P Vera |
Polycythemia Vera Polycythemia Hematologic Diseases Dasatinib |
Myeloproliferative Disorders Polycythemia vera Bone Marrow Diseases |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |