A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients

Gastrointestinal Stromal Tumor Clinical Trial

Official title: A Phase II Study of AUY922, a Novel HSP Inhibitor, in Patients With Advanced GIST Failed to or Intolerance of Imatinib and Sunitinib Therapy

Status Recruiting

Clinical Trial Summary

A Phase II Study of AUY922, Novel HSP Inhibitor, in Patients with Advanced GIST Failed to or Intolerance of Imatinib and Sunitinib Therapy

Primary endpoint:

•The primary endpoint of this study is to assess disease control rate (complete response + partial response + stable disease≧4 months) of AUY922 in patients with advanced GIST failed to imatinib and sunitinib

Secondary endpoints:

• To determinate the objective response rate (ORR, complete response + partial response)

• To determinate the time to tumor progression (TTP)

• To evaluate the safety and toxicity profiles of AUY922

• To evaluate the pharmacokinetics profile of AUY922 in Taiwan GIST population

• To access the pharmacodynamic effect of AUY922 on HSP client proteins in blood and tumor if feasible , i.e. HSP70, in Taiwan GIST population

• To access the tissue biomarkers pre-treatment and 4wks post treatment if feasible, i.e. HSP70, c-KIT, PDGFRA mutation, ...etc in Taiwan GIST population

Exploratory endpoints:

•PET imaging; sSUVmax

Clinical Trial Description

This is an open-label; pharmacokinetic and pharmacodynamic phase II study of AUY922 in patients with advanced GIST failed to or intolerance of imatinib and sunitinib therapy. AUY922 is a novel HSP90 inhibitor and will be administered at dose of 70 mg/m2 i.v. infusion on D1 every week. The Simon one sample two-stage minimax design was used with 15 suitable patients to be accrued to the first stage. If at least two patients meet our primary endpoint (complete response＋partial response＋stable disease≧4 months), an additional 10 patients would be recruited to the second stage. AUY922 would be considered active in this patient population, if there were more than 5 cases of non-progressive disease in the total cohort of 25 patients. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors

• NCT number: NCT01389583
• Study type: Interventional
• Source: National Health Research Institutes, Taiwan
• Contact: Brong-rong Chen, BS
• Phone: 886-2-2653-4401
• Email: brong@nhri.org.tw
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2011
• Completion date: October 2019