AZD9291 US Expanded Access Program
To provide access to AZD9291 for adult patients with advanced/metastatic, epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 14, 2016 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Expanded Access
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Expanded Access
- Phase
- Not applicable
- Sponsor
- AstraZeneca
- Interventions being studied
- Drug: AZD9291
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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: 1. Mean resting corrected QT interval (QTc using Fredericia's formula) \> 470 msec 2. 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) 3. 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteAnaheim, California
- Research SiteBeverly Hills, California
- Research SiteBurbank, California
- Research SiteSanta Barbara, California
- Research SiteSanta Rosa, California
- Research SiteManchester, Connecticut
- Research SiteBoca Raton, Florida
- Research SiteFleming Island, Florida
- Research SiteAthens, Georgia
- Research SiteHonolulu, Hawaii
- Research SiteChicago, Illinois
- Research SiteChevy Chase, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2016. Always confirm current availability with the study team.