AZD9291 US Expanded Access Program
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02451852 |
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Expanded Access Status :
No longer available
First Posted : May 22, 2015
Last Update Posted : July 14, 2016
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
- Study Details
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| EGFR T790M Mutation Positive NSCLC | Drug: AZD9291 |
- 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 |
| Official Title: | 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
Drug Information available for:
Osimertinib
Intervention Details:
- Drug: AZD9291
AZD9291 80mg tablet once daily, open label
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451852
Locations
| United States, California | |
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| 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 | |
| United States, Connecticut | |
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| Manchester, Connecticut, United States | |
| United States, Florida | |
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| Boca Raton, Florida, United States | |
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| Fleming Island, Florida, United States | |
| United States, Georgia | |
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| Athens, Georgia, United States | |
| United States, Hawaii | |
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| Honolulu, Hawaii, United States | |
| United States, Illinois | |
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| Chicago, Illinois, United States | |
| United States, Maryland | |
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| Chevy Chase, Maryland, United States | |
| United States, Massachusetts | |
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| Boston, Massachusetts, United States | |
| United States, Michigan | |
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| Detroit, Michigan, United States | |
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| Lansing, Michigan, United States | |
| United States, Minnesota | |
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| Rochester, Minnesota, United States | |
| United States, Nebraska | |
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| Lincoln, Nebraska, United States | |
| United States, New Jersey | |
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| Paramus, New Jersey, United States | |
| United States, New York | |
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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 | |
| United States, North Carolina | |
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| Charlotte, North Carolina, United States | |
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| Winston Salem, North Carolina, United States | |
| United States, Ohio | |
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| Columbus, Ohio, United States | |
| United States, South Dakota | |
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| Sioux Falls, South Dakota, United States | |
| United States, Texas | |
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| Austin, Texas, United States | |
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| Dallas, Texas, United States | |
| United States, Virginia | |
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| Fairfax, Virginia, United States | |
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| Warrenton, Virginia, United States | |
| United States, Washington | |
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| Lacey, Washington, United States | |
| Research Site | |
| Seattle, Washington, United States | |
Sponsors and Collaborators
AstraZeneca
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT02451852 |
| Other Study ID Numbers: |
D5160C00021 |
| First Posted: | May 22, 2015 Key Record Dates |
| Last Update Posted: | July 14, 2016 |
| Last Verified: | July 2016 |
Additional relevant MeSH terms:
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Osimertinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |