Gastrointestinal Stromal TumorPhase 2NCT01389583
A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients
A Phase 2 study testing AUY922 in people with Gastrointestinal Stromal Tumor, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastrointestinal Stromal Tumor
- What is being tested?
- AUY922
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2011to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- With adequate organ and marrow function as defined below:
- WBC ≥ 3.00 × 103/ mm3 and absolute neutrophil count ≥ 1.50 × 103/ mm3
- Platelet count ≥ 100.0 × 103/mm3
- Hemoglobin level ≥ 9 gm/dL
- Serum creatinine (Cr) ≦1.5 x UNL or eGFR ≥ 60 ml/min (by Cockroft-Gault method)
- Serum bilirubin ≤ 1.5 x UNL , ALT ≤ 2.5x UNL. If obstructive jaundice with proper drainage, serum bilirubin ≤ 3 x UNL is acceptable.
- 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
- Willing to have tumor biopsy at screening (all patients) and able to comply with study requirement at 4 weeks post treatment
- With ability to understand and the willingness to sign Informed Consent Form.
Who cannot join
- 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
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- 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
- Presence of active infection or systemic use of antimicrobials within 72 hours prior to enrolment
- Treatment with therapeutic doses of coumadin-type anticoagulants. [Maximum daily dose of 2mg, for line patency permitted]
- Patients who are unable to comply protocol requirement, i.e. tumor tissue sampling or blood sampling for pharmacodynamic and pharmacokinetics study
- Patients who have know hypersensitivity or prior therapy of any HSP90 inhibitor compound or its derivatives
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Health Research of Institutes, Taiwan Cooperative Oncology Group
Tainan
Kun-Huei Yeh, PhD
Chueh-Chuan Yen, PhD
About this study
Official title: A Phase II Study of AUY922, a Novel HSP Inhibitor, in Patients With Advanced GIST Failed to or Intolerance of Imatinib and Sunitinib Therapy
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:
Read more
•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
Read the detailed description
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.
- Conditions
- Gastrointestinal Stromal Tumor
- Being tested
- AUY922
- Keywords
- GIST(Gastrointestinal stromal tumor), HSP(Heat Shock Protein), Biomarker
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUY922Drug
70 mg/m2 60-min i.v. infusion weekly
| Study group | Role | What they receive |
|---|---|---|
| AUY922 | Experimental | AUY922 Receives: Drug: AUY922 |
What is being measured
The primary outcome is the main question the study is designed to answer.
disaese control rate
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
Measured: 4 months
Secondary outcomes (1)
response rate
- 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2015 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Mackay Memorial Hospital, Taichung Veterans General Hospital, China Medical University Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Li-Tzong Chen, M.D.,Ph.D, Principal investigator, National Health Research of Institutes, Taiwan Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389583
- Sponsor's protocol ID
- T2211
- Status last verified
- Sep 2013
- First submitted
- 6 Jul 2011
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of AUY922, a Novel HSP Inhibitor, in Patients With Advanced GIST Failed to or Intolerance of Imatinib and Sunitinib Therapy
- ClinicalTrials.gov ID
- NCT01389583
- Acronym / sponsor ID
- T2211
- Conditions
- Gastrointestinal Stromal Tumor
- Keywords
- GIST(Gastrointestinal stromal tumor), HSP(Heat Shock Protein), Biomarker
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Mackay Memorial Hospital, Taichung Veterans General Hospital, China Medical University Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital
- Study start
- Oct 2011
- Primary completion
- May 2015 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUY922 | Experimental | Drug: AUY922AUY922 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUY92270 mg/m2 60-min i.v. infusion weekly | Drug | AUY922 |
Primary outcome
disaese control rate
Time frame: 4 months
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
1 secondary outcome
response rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Tzong Chen, M.D.,Ph.D principal investigator
National Health Research of Institutes, Taiwan Cooperative Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUY922 in people with Gastrointestinal Stromal Tumor, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brong-rong Chen, BS (886-2-2653-4401 ext. 25162, brong@nhri.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disaese control rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015.