Dose Escalation of HSP990 in Japan/Korea

Novartis

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: HSP990

Study type: Interventional

Funder types: Industry

Identifiers

NCT01064089

CHSP990A1101

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with advanced solid tumors (advanced cancer)
2. Patient's disease must be evaluable using the RECIST criteria
3. Patients must be 18 or older in Korea or 20 or older in Japan
4. Patients must be relatively healthy as measured by their performance status
5. Patients must have acceptable laboratory values as measured by blood tests
6. Patients must be able to swallow capsules
7. Patients must understand the study and give written permission to enter study

Exclusion criteria

1. Patients cannot have brain tumors
2. Patients cannot have had prior medicines that are similar to the study drug or an HDAC inhibitor medicine
3. Patients must not be classified as a "poor or intermediate CYP2C9 metabolizer" as measured using a sample of their blood
4. Patients must have recovered from all previous anti-cancer therapy
5. Patients must have finished taking their previous anti-cancer therapy before entering study
6. 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.)
7. Patients must have relatively good heart function

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

HSP990

Experimental group

Description:

dose escalation

Treatment:

Drug: HSP990