Clinical Trials /

AZD9291 US Expanded Access Program

NCT02451852

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

No longer available

Trial Eligibility

Document

AZD9291 US Expanded Access Program

Title

  • Brief Title: AZD9291 US Expanded Access Program
  • 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
  • Clinical Trial IDs

    NCT ID: NCT02451852

    ORG ID: D5160C00021

    Trial Conditions

    EGFR T790M Mutation Positive NSCLC

    Trial Interventions

    Drug Synonyms Arms
    AZD9291

    Trial Purpose

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

    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

    Trial Arms

    Name Type Description Interventions

    Eligibility 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

    - 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Secondary Outcome Measures

    Trial Keywords