Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors
NCT ID: NCT01155713
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
63 participants
INTERVENTIONAL
2010-07-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm 1 - TKI258 - bioavailability
TKI258
TKI258 - food effect
TKI258
Interventions
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TKI258
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* World Health Organization (WHO) performance status ≤ 2
* Patient must meet protocol-specified laboratory values
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service
Scottsdale, Arizona, United States
Duke University Medical Center
Durham, North Carolina, United States
Sarah Cannon Research Institute Sarah Cannon Research Instit
Nashville, Tennessee, United States
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Related Links
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Results for CTKI258A2116 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CTKI258A2116
Identifier Type: -
Identifier Source: org_study_id