Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors
- Registration Number
- NCT01155713
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
- Patients with an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists
- World Health Organization (WHO) performance status ≤ 2
- Patient must meet protocol-specified laboratory values
Exclusion Criteria
- Patients with brain cancer
- 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
- Female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1 - TKI258 - bioavailability TKI258 - TKI258 - food effect TKI258 -
- Primary Outcome Measures
Name Time Method Determine the effect of food on the bioavailability of TKI258 food effect (22 days) Determine the relative bioavailability of the final market image form of TKI258 (monohydrate tablets) as compared to the clinical service form of TKI258 (anhydrate capsules) relative bioavailability (9 days)
- Secondary Outcome Measures
Name Time Method Characterize the safety and tolerability of TKI258, including acute and chronic toxicities. Up to 28 days after the last dose of study drug Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors. Every 8 weeks until progression of disease
Trial Locations
- Locations (4)
University of Utah / Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Sarah Cannon Research Institute Sarah Cannon Research Instit
🇺🇸Nashville, Tennessee, United States
Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service
🇺🇸Scottsdale, Arizona, United States