Bioavailability and Food Effect Study of TKI258 (CSF Capsules vs. FMI Capsules)in Adult Patients With Advanced Solid Tumors
A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258, and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors
1 other identifier
interventional
60
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2010
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedDecember 21, 2020
December 1, 2013
2.3 years
December 8, 2009
December 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Determine the relative bioavailability of the final market image form of TKI258 (monohydrate capsules) as compared to the clinical service form of TKI258 (anhydrate capsules)
9 days
Determine the effect of food on the bioavailability of TKI258
22 days
Secondary Outcomes (2)
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
Study Arms (2)
TKI258 - bioavailability
EXPERIMENTALTKI258 - food
EXPERIMENTALInterventions
bioavailability (anhydrate capsules) food (monohydrae capsules)
Eligibility Criteria
You may qualify if:
- Patients with an advanced solid tumor, except breast cancer,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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California at Los Angeles
Los Angeles, California, 90095, United States
Duke University Medical Center Cancer Dept
Durham, North Carolina, 27710, United States
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Related Links
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2009
First Posted
December 11, 2009
Study Start
February 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
December 21, 2020
Record last verified: 2013-12