Dose Escalation of HSP990 in Japan/Korea

Phase 1

Terminated

• Conditions: Advanced Solid Tumors
• Interventions: Drug: HSP990

• Registration Number: NCT01064089
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-12
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSP990	HSP990	dose escalation

Primary Outcome Measures

Name	Time	Method
establish maximum tolerated dose (MTD)	2.5 years

Secondary Outcome Measures

Name	Time	Method
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
Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD)	2.5 years
Measurement of biomarkers for HSP90 pathway in blood and tissue	2.5 years
Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events	2.5 years

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Kashiwa, Chiba, Japan