A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients (NCT01389583) | Clinical Trial Compass
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 range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
disaese control rate
Timeframe: 4 months
Trial details
NCT IDNCT01389583
SponsorNational Health Research Institutes, Taiwan
. 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
. Have received imatinib or sunitinib, chemotherapy, any investigational agents or participate in any investigational drug study within 28 days before enrolment
. Have major surgery within 28 days before enrolment (diagnostic biopsy or line placement is not considered major surgery)
. With active multiple cancers or history of other malignancy within the last three years, except treated curable non-melanoma skin cancer, in-situ cervical cancer, Dukes' A colorectal cancer.
. With known CNS metastasis
. Symptoms of heart failure or greater to Class III (by NYHA criteria) or history of uncontrolled dysrrhythmias
. Sinus bradycardia (resting heart rate \<50 beats/min) secondary to intrinsic conduction system disease; Patients with sinus bradycardia secondary to pharmacologic treatment may enrol if they are allowed to withdraw the treatment and can result in normalization of the resting heart rate to within normal limits
. Myocardial infarction or active ischemic heart within 6 months
. Screening QTc \>450 msec in males; QTc \>470 msec in females, or previous history of QTc prolongation while taking other medications