Bioavailability and Food Effect Study of TKI258 (CSF Capsules vs. FMI Capsules)in Adult Patients With Advanced Solid Tumors
NCT ID: NCT01030055
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
60 participants
INTERVENTIONAL
2010-02-28
2012-06-30
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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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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TKI258 - bioavailability
TKI258 (dovitinib)
bioavailability (anhydrate capsules) food (monohydrae capsules)
TKI258 - food
TKI258 (dovitinib)
bioavailability (anhydrate capsules) food (monohydrae capsules)
Interventions
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TKI258 (dovitinib)
bioavailability (anhydrate capsules) food (monohydrae capsules)
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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City of Hope National Medical Center
Duarte, California, United States
University of California at Los Angeles
Los Angeles, California, United States
Duke University Medical Center Cancer Dept
Durham, North Carolina, 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 CTKI258A2112 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CTKI258A2112
Identifier Type: -
Identifier Source: org_study_id