A Phase I, Open-label, Multi-center, Randomized, Crossover Study to Assess the Bioequivalence of 2 Formulations of TKI258, FMI Capsule and FMI Tablet, in Patients With Advanced Solid Tumors
Interventional
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Composite of Pharmacokinetics of TKI258, FMI capsule (supplied in 100 mg strength) and FMI tablet (supplied in 250 mg strength), in patients with advanced solid tumors, excluding breast cancer based on PK parameters AUClast and Cmax
9 days
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CTKI258A2128
NCT01421004
December 2011
January 2013
Name | Location |
---|---|
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) | San Antonio, Texas 78229 |
UCLA/ University of California Los Angeles UCLA LeConte Location | Los Angeles, California 90095 |
University of Wisconsin Univ Wisc | Madison, Wisconsin 53792 |
University of Utah / Huntsman Cancer Institute Huntsman | Salt Lake City, Utah 84103 |
City of Hope National Medical Center SC-2 | Duarte, California 91010-3000 |
University of California San Francisco UCSF (SC) | San Francisco, California |
Florida Cancer Specialists Sarasota Office | Fort Myers, Florida 33901 |
Rush University Medical Center Rush 3 | Chicago, Illinois 60612 |
Washington University School Of Medicine-Siteman Cancer Ctr SC | St. Louis, Missouri 63110 |
Montefiore Medical Center Montefiore Medical Center (SC) | Bronx, New York 10467 |
University of Oklahoma Health Sciences Center OUHSC - SC | Oklahoma City, Oklahoma 73104 |
University of Pittsburgh University of Pittsburgh (SC) | Pittsburgh, Pennsylvania 15232-1305 |
Sarah Cannon Research Institute Sarah Cannon Research (SC) | Nashville, Tennessee 37203 |
Sammons Cancer Center Sammons Cancer Center SC-2 | Dallas, Texas 78246 |