- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02451852
AZD9291 US Expanded Access Program
July 13, 2016 updated by: AstraZeneca
A Multi-center, AZD9291 Expanded Access Program for the Treatment of Patients With Advanced/Metastatic EGFR T790M Mutation-positive Non-small Cell Lung Cancer (NSCLC) Who Have Received Prior EGFR TKI Therapy
To provide access to AZD9291 for adult patients with advanced/metastatic, epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Detailed Description
- This is a multi-center, AZD9291 expanded access protocol for the treatment of adult patients with advanced/metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) who have received prior EGFR TKI therapy and at least one additional line of therapy (≥ 3rd line).
Local testing is accepted for confirmation of T790 mutation status.
Eligible patients will be enrolled to receive AZD9291 (80mg orally, once daily) for as long as the access program remains open and they are continuing to show clinical benefit, as judged by the treating physician
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Anaheim, California, United States
- Research Site
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Beverly Hills, California, United States
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Burbank, California, United States
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Santa Barbara, California, United States
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Santa Rosa, California, United States
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Connecticut
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Manchester, Connecticut, United States
- Research Site
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Florida
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Boca Raton, Florida, United States
- Research Site
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Fleming Island, Florida, United States
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Georgia
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Athens, Georgia, United States
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Hawaii
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Honolulu, Hawaii, United States
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Illinois
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Chicago, Illinois, United States
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Maryland
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Chevy Chase, Maryland, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Detroit, Michigan, United States
- Research Site
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Lansing, Michigan, United States
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Minnesota
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Rochester, Minnesota, United States
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Nebraska
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Lincoln, Nebraska, United States
- Research Site
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New Jersey
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Paramus, New Jersey, United States
- Research Site
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New York
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Buffalo, New York, United States
- Research Site
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Fresh Meadows, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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Winston Salem, North Carolina, United States
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Ohio
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Columbus, Ohio, United States
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South Dakota
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Sioux Falls, South Dakota, United States
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Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Virginia
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Fairfax, Virginia, United States
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Warrenton, Virginia, United States
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Washington
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Lacey, Washington, United States
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Seattle, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 130 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any treatment protocol-specific procedures
- Patients aged at least 18 years
- Locally advanced or metastatic EGFRm NSCLC, not amenable to curative surgery or radiotherapy with confirmation of the presence of the T790M mutation
- Two lines of prior therapy including at least one EGFR TKI
- World Health Organization (WHO) performance status 0-2.
- Females of child-bearing potential must use adequate contraceptive measures, not be breast-feeding and have negative pregnancy test prior to start of dosing.
- Males patients should be willing to use barrier contraception.
Exclusion Criteria:
- Previous treatment with AZD9291
- Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of AZD9291) any treatment known to be potent inhibitors or inducers of CYP3A4
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or significantly impaired bone marrow reserve or organ function, including hepatic and renal impairment, which in the clinician's opinion would significantly alter the risk/benefit balance, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- Patients with symptomatic CNS metastases who are neurologically unstable
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc using Fredericia's formula) > 470 msec
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
- Any unresolved toxicity from prior therapy Common Terminology Criteria for Adverse Events (CTCAE) > grade 3 at the time of starting treatment in the access program
- History of hypersensitivity to AZD9291 (or drugs with a similar chemical structure or class to AZD9291) or any excipients of these agents
- Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to access program entry
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
May 20, 2015
First Submitted That Met QC Criteria
May 20, 2015
First Posted (Estimate)
May 22, 2015
Study Record Updates
Last Update Posted (Estimate)
July 14, 2016
Last Update Submitted That Met QC Criteria
July 13, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5160C00021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on EGFR T790M Mutation Positive NSCLC
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AstraZenecaCompletedCaucasian Patients With EGFR Mutation Positive Advanced NSCLCBulgaria, Italy, Poland, Spain, Turkey, United Kingdom, Romania, Norway, Hungary, Portugal, Greece, Switzerland, France
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AstraZenecaCompletedLocally Advanced or Metastatic EGFR T790M+ NSCLCCanada, Korea, Republic of, Taiwan
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Tianjin Medical University Cancer Institute and...Not yet recruitingNSCLC | EGFR Activating Mutation | Anlotinib | TP53 | Aumolertinib
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University Hospital, EssenCompletedNSCLC | EGFR T790M | FDG-PETGermany
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Chinese University of Hong KongPamela Youde Nethersole Eastern HospitalCompleted
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Astellas Pharma Global Development, Inc.WithdrawnSubjects With NSCLC With an EGFR Activating Mutation
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AstraZenecaCompletedNon-small Cell Lung CancerSweden
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AstraZenecaCompletedCarcinoma, Non-Small-Cell Lung With EGFR Mutation PositiveChina
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AstraZenecaTigerMedCompleted
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AstraZenecaCompletedHealthy VolunteerUnited States