Phase I Dose Escalating Study of TKI258

Study Overview
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Brief Summary
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The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.

Official Title
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A Phase I Dose Escalating Study to Evaluate TKI258 Administered Orally on a 5 Days on/2days Off Schedule in Japanese Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: TKI258


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained prior to any screening procedures Advanced solid tumors Agreement to remaining hospitalized ECOG performance status of 0 or 1 Life expectancy of at least 3 months Pregnant women. Male and female patients of reproductive potential must agree to employ an effective method of birth control Demonstrate the specific hematological /blood chemistry laboratory values Exclusion Criteria: Receipt of any investigational compound within 28 days prior to the first dose of study drug or failure to have recovered from the side effects of such prior therapy Receipt of other antineoplastic therapy, including chemo-, hormonal, immuno-, and radiation therapy, within 28 days (with some exceptions) Patients with CNS and/or leptomeningeal disease metastases Presence or history of thromboembolic or cerebrovascular events Impaired cardiac function or clinically significant cardiac disease Malabsorption syndrome or uncontrolled gastrointestinal toxicities Patients known to be HIV- or HBV- or HCV- positive Patients with acute or chronic uncontrolled infection Patients who have undergone surgery with general anesthesia for any cause within 28 days prior to the first dose of study drug Patients who have been receiving anticoagulant therapy Receipt of any hematopoietic colony stimulating factor or blood transfusion within 14 days prior to the first dose of study drug Patients who have been administering concomitant medication which may prolong the QTc interval Patients with interstitial pneumonia or pulmonary fibrosis proven on a chest CT scan Patients with a large volume of ascitic and/or pleural fluid which requires drainage Patients with any bone fractures Deemed otherwise unsuitable by the investigator Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TKI258<br>dose escalation | 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 |
| --- | --- | --- |
| Maximum tolerated dose (MTD) of TKI258 |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antineoplastic activity based on the RECIST criteria |  | 22 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor, cancer, phase1, TKI258