Study of Hsp90 Inhibitor AUY922 for the Treatment of Patients With Refractory Gastrointestinal Stromal Tumor

Gastrointestinal Stromal Tumor Clinical Trial

Official title: A Phase II Study of Hsp90 Inhibitor AUY922 for the Treatment of Patients With Refractory Gastrointestinal Stromal Tumor

Status Completed

Clinical Trial Summary

This is a multicenter, non-randomized, single agent, Phase II study of AUY922 in patients with refractory Gastrointestinal Stromal Tumor (GIST). The primary endpoint of this study is to determine progression-free survival (PFS) for patients with GIST receiving AUY922 intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle with restaging at 6 and 12 weeks and then every 9 weeks thereafter. Patients may continue treatment until evidence of disease progression.

Clinical Trial Description

Preclinical data have shown that Hsp90 inhibition can lead to decrease in tumor growth of GIST tumors that are both imatinib-sensitive and imatinib-resistant (Bauer 2006). A recently reported phase I trial evaluated Hsp90 inhibitor IPI-504 for the treatment of patients with GIST refractory to tyrosine kinase inhibitors (Wagner 2008). In this study, 100% of patients had been previously exposed to imatinib and 93% to sunitinib. For 36 patients treated on this trial, the partial response (PR) rate was 3% and stable disease (SD) was 67%, with a median PFS of 12 weeks. This is significantly improved over a placebo median PFS of 6 weeks for patients treated with sunitinib versus placebo who were refractory for imatinib (Demetri 2006). ;

Study Design

Endpoint Classification: Safety/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: NCT01404650
• Study type: Interventional
• Source: SCRI Development Innovations, LLC
• Status: Completed
• Phase: Phase 2
• Start date: December 2011
• Completion date: February 2015