A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients
Status:
Unknown status
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Chang Gung Memorial Hospital China Medical University Hospital Mackay Memorial Hospital National Cheng-Kung University Hospital National Taiwan University Hospital Taichung Veterans General Hospital Taipei Veterans General Hospital, Taiwan