Spots Global Cancer Trial Database for A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients

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Trial Identification

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

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

Study ID: NCT01389583

Conditions

Gastrointestinal Stromal Tumor

Interventions

AUY922

Study Description

Brief 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

Detailed 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.