A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280

Official Title
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A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: INC280


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 Good organ (hepatic, kidney, BM) function at screening/baseline visit. Exclusion criteria: Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280. Undergone a bone marrow or solid organ transplant. Women who are pregnant or breast feeding. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INC280<br> | Drug: INC280<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part | Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events and serious adverse events, changes in laboratory values | Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment. | 4 months | 
| Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2 | Plasma concentration of INC280 and derived PK parameters of INC280 will be measured with serial plasma samples during treatment for first months. | 1 month | 
| Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM | Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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c-MET, Advanced solid tumor