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NCT01155713 Clinical Trial

Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) 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 (CSF Capsule vs. FMI Tablet), 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 NCT01155713
Other study ID # CTKI258A2116
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 2010
Est. completion date November 2013

Study information
Verified date May 2016
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 63
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 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

Locations
Country Name City State
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 Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service Scottsdale Arizona

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 tablets) as compared to the clinical service form of TKI258 (anhydrate capsules) relative bioavailability (9 days)
Primary Determine the effect of food on the bioavailability of TKI258 food effect (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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