Non Small Cell Lung Cancer Clinical Trial
Official title:
Phase II Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR
Verified date | March 2018 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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" means that the drug is being studied. It also means that the FDA has not
yet approved the drug for your type of cancer or for any use outside of research studies.
It has been found that some people with NSCLC have a change (mutation) in a certain gene
called the EGFR gene. This mutated gene helps cancer cells grow. The majority of NSCLC
patients with EGFR mutations achieve good outcomes with erlotinib or other EGFR inhibitor
therapies, with a high response rate, prolonged progression-free survival and possibly
improved overall survival from therapy. However, the 4% of EGFR mutant patients that harbor
an exon 20 insertion mutation historically have reaped little benefit from EGFR-directed
therapy due to the low affinity of this mutation for direct EGFR inhibitors, especially
erlotinib and gefitinib (see Yasuda et al, Lancet Oncol 2011). This group of patients is
ideal for studying other targeted therapeutic strategies that could affect the oncogene
mutation in EGFR via alternative mechanisms.
AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This
drug has been used in other research studies. Information from those other research studies
suggests that AUY922 may be effective in killing cancer cells in patients with exon 20
insertion mutations in EGFR.
The purpose of this study is to test the safety of AUY922 and determine how well AUY922 works
for participants with advanced NSCLC and exon 20 insertion mutations in EGFR.
Status | Completed |
Enrollment | 29 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate | The number of participants that achieved a response to treatment as assessed by Response Evaluation Criteria is Solid Tumors (RECIST). Response is defined as having achieved either a complete response (CR) or a partial response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
From the start of treatment until the time of disease progression, median duration of follow-up of about 3 months | |
Secondary | Median Progression Free and Overall Survival | Overall survival (OS) is measured from the start of treatment until the time of death. Progression free survival is measured from the start of treatment until the time of death or disease progression as assessed by RECIST. Progressive disease is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression. | From the start of treatment until the time or death or disease progression | |
Secondary | The Number of Participants With Treatment Related Serious Adverse Events | The number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) that were deemed to be possibly, probably, or definitely related to study treatment as determined by the treating physician. | From the start of treatment until 28 days after the end of treatment | |
Secondary | Exon 20 EGFR Mutations Among Participants That Responded to Treatment | The specific exon 20 epidermal growth factor receptor (EGFR) mutations among participants that achieved either a partial response or complete response as assessed by RECIST. The EGFR mutations were assessed from biopsies taken at baseline and then the baseline mutations were categorized by disease response. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
Baseline, at the time of response |
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