Dose Escalation of HSP990 in Japan/Korea

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01064089
• Other study ID #: CHSP990A1101
• Status: Terminated
• Phase: Phase 1
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: December 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• HSP990

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	establish maximum tolerated dose (MTD)		2.5 years
Secondary	Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events		2.5 years
Secondary	Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD)		2.5 years
Secondary	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
Secondary	Measurement of biomarkers for HSP90 pathway in blood and tissue		2.5 years

External Links

•   Results for CHSP990A1101 can be found on the Novartis Clinical Trial Results Website