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
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
70 mg/m2 60-min i.v. infusion weekly
National Health Research of Institutes, Taiwan Cooperative Oncology Group
Tainan, Taiwan
RECRUITINGdisaese control rate
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
Time frame: 4 months
response rate
* 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
Time frame: 3 years
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