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

NCT01389583 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-02-25

No results posted yet for this study

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

Conditions

  • Gastrointestinal Stromal Tumor

Interventions

DRUG

AUY922

70 mg/m2 60-min i.v. infusion weekly

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Mackay Memorial Hospital

    collaborator OTHER

  • Taichung Veterans General Hospital

    collaborator OTHER

  • China Medical University Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Li-Tzong Chen, M.D.,Ph.D · National Health Research of Institutes, Taiwan Cooperative Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-05-31
Completion
2019-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01389583 on ClinicalTrials.gov