A Single Arm, Phase II, Open-Label Study to Determine the Efficacy of 100mg Twice Daily Oral Dosing of Midostaurin Administered to Patients With Aggressive Systemic Mastocytosis or Mast Cell Leukemia +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate according to established criteria by assessing clinical findings at the end of 6 cycles
at the end of 6 cycles
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CPKC412D2201
NCT00782067
October 2008
July 2013
Name | Location |
---|---|
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Oregon Health & Science University Dept. Hematologic Malignancies | Portland, Oregon 97239 |
Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia | Augusta, Georgia 30912 |
University of California at Los Angeles Dept. of Hematology Clinic | Los Angeles, California 90095 |
Dana Farber Cancer Institute Hematology / Oncology | Boston, Massachusetts 02115 |
Stanford University Medical Center Stanford University 2 | Stanford, California 94305-5750 |
University of Colorado Dept of Univ. of Colorado | Aurora, Colorado 80045 |
University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(3) | Ann Arbor, Michigan 48109-0944 |
Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2) | New York, New York 10021 |
Virginia Commonwealth University SC | Richmond, Virginia 23284 |