AZD9291 US Expanded Access Program
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
1 other identifier
expanded_access
N/A
1 country
32
Brief Summary
To provide access to AZD9291 for adult patients with advanced/metastatic, epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
32 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedJuly 14, 2016
July 1, 2016
May 20, 2015
July 13, 2016
Conditions
Interventions
AZD9291 80mg tablet once daily, open label
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (32)
Research Site
Anaheim, California, United States
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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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Manchester, Connecticut, United States
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Boca Raton, Florida, United States
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Fleming Island, Florida, United States
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Athens, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Chevy Chase, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Lansing, Michigan, United States
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Rochester, Minnesota, United States
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Lincoln, Nebraska, United States
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Paramus, New Jersey, United States
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Buffalo, New York, United States
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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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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Sioux Falls, South Dakota, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fairfax, Virginia, United States
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Warrenton, Virginia, United States
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Lacey, Washington, United States
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Seattle, Washington, United States
MeSH Terms
Interventions
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2015
First Posted
May 22, 2015
Last Updated
July 14, 2016
Record last verified: 2016-07