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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neoplasm, Cancer, Tumors

Intervention / Treatment
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* Drug: TKI258


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - TKI258 - bioavailability<br> | Drug: TKI258<br> <br> * Other names: Dovitinib;|
| Experimental: TKI258 - food effect<br> | Drug: TKI258<br> <br> * Other names: Dovitinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Cancer, Tumors, Administration, oral, Capsules, CHIR258, CHIR-258, CHIR 258, TKI258, TKI-258, TKI 258,, Bioavailability,, Food