UnknownPhase 2

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

Taiwan25 participantsStarted 2011-10

Plain-language 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

Who can participate

Age range20 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patients with histologically proven CD117-positive and/or c-kit or PDGFR mutation gastrointestinal stromal tumor (GIST), which is metastatic or unresectable, locally advanced, and have failed to or intolerance of prior imatinib and sunitinib treatment
✓. At least one measurable lesion according to the RECIST criteria (version 1.1)
✓. Aged between 20-75 years
✓. With Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
✓. Life expectancy ≥ 4 months
✓. At least 4 weeks apart from prior systemic (including chemotherapy, approved targeted therapy or investigational agent) and surgical treatment, and recovery from all prior treatment-related toxicity to grade \< 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
✓. With adequate organ and marrow function as defined below:
✓. Women of childbearing potential and men must agree to use accepted methods of contraception during the course of the study and at least 3 months after last dose of treatment

Exclusion criteria

What they're measuring

disaese control rate

Timeframe: 4 months

Trial details

NCT IDNCT01389583

SponsorNational Health Research Institutes, Taiwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-05

Contact for this trial

Brong-rong Chen, BS

886-2-2653-4401 brong@nhri.org.tw

View on ClinicalTrials.gov More Gastrointestinal Stromal Tumor trials