Dose Escalation of HSP990 in Japan/Korea

NCT ID: NCT01064089

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HSP990 HSP90 Japan/Korea Phase I advanced solid tumors dose escalation maximum tolerated dose MTD Japanese paatients Korean patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HSP990

dose escalation

Group Type EXPERIMENTAL

HSP990

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HSP990

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Kashiwa, Chiba, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea Japan

Related Links

Access external resources that provide additional context or updates about the study.

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7623

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHSP990A1101

Identifier Type: -

Identifier Source: org_study_id