Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
- Registration Number
- NCT01421004
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
- Patients with a histopathologically or cytopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer, who have progressed despite standard therapy, or for which no standard therapy exists
- ECOG performance status (PS) 0, 1 or 2
- Patients must meet protocol-specified laboratory values
- Patients with brain metastases
- Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- Patients who have not recovered from previous anti-cancer therapies
- Patients who are expected to receive any prohibited medications during the bioequivalence phase of the study
- Female patients who are pregnant, breast feeding
- Fertile male or women of child-bearing potential not willing to use two highly effective methods of contraception
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 500 mg FMI capsule + 250 mg FMI tablet TKI258 BE phase sequence 1= 3 weeks on FMI capsule then 1 week on FMI tablet 500 mg TKI258 FMI capsule +250 mg FMI tablet TKI258 BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Preliminary evidence of anti-tumor activity based on RECIST criteria of TKI258 in patients with advanced solid tumors, excluding breast cancer Every 8 weeks until progression of disease Frequency of Adverse Events in patients treated with TKI258 on a 5 days on/2 days off dosing schedule in patients with advanced solid tumors, excluding breast cancer up to 30 days after the last dose of study drug
Trial Locations
- Locations (14)
Rush University Medical Center Rush 3
🇺🇸Chicago, Illinois, United States
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
Florida Cancer Specialists Sarasota Office
🇺🇸Fort Myers, Florida, United States
Washington University School of Medicine SC
🇺🇸Saint Louis, Missouri, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Sammons Cancer Center - Texas Oncology SC-2
🇺🇸Dallas, Texas, United States
University of California San Francisco UCSF (SC)
🇺🇸San Francisco, California, 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
Sarah Cannon Research Institute Sarah Cannon Research (SC)
🇺🇸Nashville, Tennessee, 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