Status:
COMPLETED
Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neoplasm
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01155713
Start Date
July 1 2010
End Date
November 1 2013
Last Update
December 21 2020
Active Locations (4)
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1
Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service
Scottsdale, Arizona, United States, 85258
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Sarah Cannon Research Institute Sarah Cannon Research Instit
Nashville, Tennessee, United States, 37203
4
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112