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NCT01030055 Clinical Trial

Bioavailability and Food Effect Study of TKI258 (CSF Capsules vs. FMI Capsules)in Adult Patients With Advanced Solid Tumors

Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01030055
Other study ID # CTKI258A2112
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2010
Est. completion date June 2012

Study information
Verified date December 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 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

Related Conditions & MeSH terms

Intervention

Drug:
• TKI258 (dovitinib)
bioavailability (anhydrate capsules) food (monohydrae capsules)

Locations
Country Name City State
United States City of Hope National Medical Center Duarte California
United States Duke University Medical Center Cancer Dept Durham North Carolina
United States University of California at Los Angeles Los Angeles California
United States University of Utah / Huntsman Cancer Institute Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Determine the effect of food on the bioavailability of TKI258 22 days
Secondary Characterize the safety and tolerability of TKI258, including acute and chronic toxicities Up to 28 days after the last dose of study drug
Secondary Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors. Every 8 weeks until progression of disease
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