AZD9291 US Expanded Access Program

NO_LONGER_AVAILABLE

Conditions studied: EGFR T790M Mutation Positive NSCLC

In brief

To provide access to AZD9291 for adult patients with advanced/metastatic, epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer.

Key facts

Study ID

NCT02451852

Run by

AstraZeneca

Last updated by the study team

2016-07-14

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Research Site — Anaheim, California, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Burbank, California, United States
• Research Site — Santa Barbara, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Manchester, Connecticut, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Fleming Island, Florida, United States
• Research Site — Athens, Georgia, United States
• Research Site — Honolulu, Hawaii, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Chevy Chase, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Lansing, Michigan, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Lincoln, Nebraska, United States
• Research Site — Paramus, New Jersey, United States
• Research Site — Buffalo, New York, United States
• Research Site — Fresh Meadows, New York, United States
• Research Site — Mineola, New York, United States
• Research Site — New York, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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