Status:
COMPLETED
Phase 2 Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" m...
Detailed Description
Interested patients will be asked to undergo some screening tests and procedures to confirm that they are eligible. Many of these tests and procedures are likely to be part of regular cancer care and ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed stage IV or recurrent NSCLC
- Measurable disease by RECIST 1.0
- Must have received at least one prior line of therapy for advanced lung cancer (no maximum number)
- Life expectancy of at least 12 weeks
Exclusion
- Pregnant or breastfeeding
- Radiation within 2 weeks
- Cytotoxic chemotherapy or monoclonal antibodies within 4 weeks
- EGFR tyrosine kinase inhibitor within 2 weeks
- Other small molecule inhibitor within 2 weeks
- Experimental treatment within 30 days
- Prior treatment with any HSP90 or HDAC inhibitor compound
- Known and untreated brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to AUY922
- Unresolved diarrhea greater than or equal to CTCAE version 4, grade 1
- Major surgery within 2 weeks of starting study drug or have not recovered from side effects of surgery
- Known disorders due to a deficiency in bilirubin glucuronidation
- Requiring use of therapeutic doses of warfarin (Coumadin)
- History of long QT syndrome
- History of clinically manifest ischemic heart disease, heart failure or left ventricular dysfunction
- Clinically significant ECG abnormalities
- Other clinically significant heart disease
- Currently receiving treatment with any medication which has a relative risk of prolonging the QTc interval or inducing Torsades de Pointes
- On a cardiac pacemaker
- Concurrent malignancies or invasive cancers diagnosed within 3 years except for adequately treated basal cell cancer of the skin or in situ cancer of the cervix
- Known to be HIV positive
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01854034
Start Date
July 1 2013
End Date
March 1 2017
Last Update
April 10 2018
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215