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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01155713

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

15.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Cancer Tumors	Drug: TKI258	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 - TKI258 - bioavailability	Drug: TKI258 Other Names: Dovitinib
Experimental: TKI258 - food effect	Drug: TKI258 Other Names: Dovitinib

Arm

Intervention/Treatment

Experimental: Arm 1 - TKI258 - bioavailability

Drug: TKI258

Other Names:

Dovitinib

Experimental: TKI258 - food effect

Drug: TKI258

Other Names:

Dovitinib

Outcome Measures

Primary Outcome Measures

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)]
Determine the effect of food on the bioavailability of TKI258 [food effect (22 days)]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service	Scottsdale	Arizona	United States	85258
2	Duke University Medical Center	Durham	North Carolina	United States	27710
3	Sarah Cannon Research Institute Sarah Cannon Research Instit	Nashville	Tennessee	United States	37203
4	University of Utah / Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112