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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-11-30

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.

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Detailed Description

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Conditions

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Neoplasm Cancer Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 - TKI258 - bioavailability

Group Type EXPERIMENTAL

TKI258

Intervention Type DRUG

TKI258 - food effect

Group Type EXPERIMENTAL

TKI258

Intervention Type DRUG

Interventions

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TKI258

Intervention Type DRUG

Other Intervention Names

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Dovitinib

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No