Dose Escalation of HSP990 in Japan/Korea

Study Overview
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Brief Summary
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This study is a phase I dose escalation, multi-center, open-label study of HSP990 administered orally once weekly in adult Japanese and Korea patients with advanced solid malignancies.

Official Title
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A Phase I Dose Escalation, Multi-center, Open-label Study of HSP990 Administered Orally Once Weekly in Adult Japanese and Korea Patients With Advanced Solid Malignancies

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: HSP990


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced solid tumors (advanced cancer) Patient's disease must be evaluable using the RECIST criteria Patients must be 18 or older in Korea or 20 or older in Japan Patients must be relatively healthy as measured by their performance status Patients must have acceptable laboratory values as measured by blood tests Patients must be able to swallow capsules Patients must understand the study and give written permission to enter study Exclusion Criteria: Patients cannot have brain tumors Patients cannot have had prior medicines that are similar to the study drug or an HDAC inhibitor medicine Patients must not be classified as a poor or intermediate CYP2C9 metabolizer as measured using a sample of their blood Patients must have recovered from all previous anti-cancer therapy Patients must have finished taking their previous anti-cancer therapy before entering study Patients must not have a severe disease at the time of study entry (for example: severe diarrhea, disease of the liver or kidney, other cancers, etc.) Patients must have relatively good heart function 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSP990<br>dose escalation | Drug: HSP990<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| establish maximum tolerated dose (MTD) |  | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events |  | 2.5 years | 
| Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD) |  | 2.5 years | 
| Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples |  | 2.5 years | 
| Measurement of biomarkers for HSP90 pathway in blood and tissue |  | 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSP990, HSP90, Japan/Korea, Phase I, advanced solid tumors, dose escalation, maximum tolerated dose, MTD, Japanese paatients, Korean patients