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Sunitinib

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AUY922

Brong-rong Chen, BS

Kun-Huei Yeh, PhD

Chueh-Chuan Yen, PhD

Ken-Hong Lim, MD

Jen-Shi Chen

Cheng-Chung Wu, MS

Chang-Fang Chiu, PhD

Kuan-Der Lee, PhD

Kun-Ming Rau, MPH

Ann-Lii Cheng, PhD

Yu-Lin Lin, MD

Ta-Chung Chao, MD

Wen-Liang Fang, MD

Ruey-Kuen Hsieh, MD

Chun-Nan Yeh, MD

Youngsen Yang, MD

Tseng-Hsi Lin, PhD

Mei-Due Yang, PhD

Li-Yuan Bai, MD

Wu-Chou Su, MD

Yan-Shen Shan, PhD

Nai-Jung Chiang, MD

Yen-Yang Chen, MD

Li-Tzong Chen, M.D.,Ph.D

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.

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

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

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

* 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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients	NCT01389583	Gastrointestina...	AUY922	20 Years - 75 Years	National Health Research Institutes, Taiwan
A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients	NCT01389583	Gastrointestina...	AUY922	20 Years - 75 Years	National Health Research Institutes, Taiwan

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