Spots Global Cancer Trial Database for Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
Official Title: 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
Study ID: NCT01421004
Interventions
Study Description
Brief Summary: This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate that those 2 formulations are considered to be the same for all intents and purposes by making sure they are acting on the body with the same strength and are absorbed in similar amounts by the body. During the bioequivalence phase, patients will take orally at a daily dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days on/2days off dosing schedule, after which time, patients will switch to the alternate formulation for one additional week. After the bioequivalence phase, all patients may continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center SC-2, Duarte, California, United States
University of California at Los Angeles UCLA LeConte Location, Los Angeles, California, United States
University of California San Francisco UCSF (SC), San Francisco, California, United States
Florida Cancer Specialists Sarasota Office, Fort Myers, Florida, United States
Rush University Medical Center Rush 3, Chicago, Illinois, United States
Washington University School of Medicine SC, Saint Louis, Missouri, United States
Montefiore Medical Center Montefiore Medical Center (SC), Bronx, New York, United States
University of Oklahoma Health Sciences Center OUHSC - SC, Oklahoma City, Oklahoma, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute Sarah Cannon Research (SC), Nashville, Tennessee, United States
Sammons Cancer Center - Texas Oncology SC-2, Dallas, Texas, United States
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5), San Antonio, Texas, United States
University of Utah / Huntsman Cancer Institute Huntsman, Salt Lake City, Utah, United States
University of Wisconsin Univ Wisc, Madison, Wisconsin, United States
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Name: Novartitis Pharmaceuticals
Affiliation: Novartitis Pharmaceuticals
Role: STUDY_DIRECTOR
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