Dose Escalation of HSP990 in Japan/Korea

NCT01064089 | Terminated Phase 1

• 1 other identifier: CHSP990A1101
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• establish maximum tolerated dose (MTD)

  2.5 years

Secondary Outcomes (4)

• 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

Study Arms (1)

HSP990

EXPERIMENTAL

dose escalation

Drug: HSP990

Interventions

HSP990 DRUG

HSP990

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Nagoya, Aichi-ken, 466-8560, Japan

Location

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Location

Related Links

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

MeSH Terms

Interventions

2-amino-7-(4-fluoro-2-(6-methoxypyridin-2-yl)phenyl)-4-methyl-7,8-dihydropyrido(4,3-d)pyrimidin-5(6H)-one

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 8, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: December 8, 2020

Record last verified: 2012-12

Locations

JP (2)