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Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy

NCT02271139

Description:

This is an open-label, multicenter, single-arm, expanded access study designed to provide alectinib to participants with ALK-rearranged NSCLC after disease progression on or intolerance to prior ALK tyrosine kinase inhibitor (TKI) therapy. Participants will receive alectinib until disease progression, unacceptable toxicity, withdrawal of consent, patient or physician decision to discontinue treatment, death, alectinib becomes commercially available in the United States following approval of alectinib by the FDA, or the Sponsor decides to close the trial, whichever occurs first (approximately 15 months).

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

No longer available

Trial Eligibility

Document

Expanded Access Study of <span class="go-doc-concept go-doc-intervention">Alectinib</span> for Patients With <span class="go-doc-concept go-doc-biomarker">ALK</span>-<span class="go-doc-concept go-doc-keyword">Rearranged</span> Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> After Disease Progression on or Intolerance to Prior <span class="go-doc-concept go-doc-biomarker">ALK</span> <span class="go-doc-concept go-doc-intervention">Tyrosine Kinase Inhibitor</span> Therapy

Title

  • Brief Title: Expanded Access Study of Alectinib for Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
  • Official Title: An Open Label, Multicenter, Single-Arm, Expanded Access Study of Alectinib for Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
  • Clinical Trial IDs

    NCT ID: NCT02271139

    ORG ID: ML29453

    Trial Conditions

    Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Alectinib Expanded Access Program

    Trial Purpose

    This is an open-label, multicenter, single-arm, expanded access study designed to provide
    alectinib to patients with anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small
    cell lung cancer (NSCLC) after disease progression on or intolerance to prior ALK TKI
    therapy.

    Approximately 120 patients may be enrolled at approximately 50 sites in the United States.
    Screening will occur over a 28-day period, after which eligible patients will initiate study
    treatment with alectinib. Study treatment will continue until disease progression,
    unacceptable toxicity, withdrawal of consent, patient or physician decision to discontinue
    treatment, death, alectinib becomes commercially available in the United States following
    approval of alectinib by the FDA, or the Sponsor decides to close the trial, whichever
    occurs first.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Expanded Access Program Experimental Alectinib

    Eligibility Criteria

    Inclusion Criteria:

    - Patients with locally advanced (American Joint Committee on Cancer [AJCC] Stage IIIB)
    not amenable to curative therapy or metastatic (AJCC Stage IV) NSCLC

    - Life expectancy of at least 12 weeks

    - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-3

    - Histologically confirmed NSCLC

    - Documented ALK rearrangement as assessed by approved fluorescence in situ
    hybridization (FISH) test, using the Vysis ALK Break Apart FISH Probe Kit or the
    Ventana immunohistochemistry (IHC) test

    - After disease progression on or intolerance to prior ALK TKI therapy:

    - Patients need to have a minimum washout period of at least 5 half-lives between the
    last dose of ALK TKI therapy or other targeted therapies and the first dose of study
    treatment

    - Patients must have recovered from treatment toxicities to </= Grade 1 or to their
    pretreatment levels (for patients who have developed ILD, they must have fully
    recovered).

    - Patients can either be chemotherapy-nave or have received at least one line of
    platinum-based chemotherapy for locally advanced or metastatic disease

    - Recovery from effects of any major surgery or significant traumatic injury at least
    28 days before the first dose of study treatment

    - Adequate hematological and renal function

    - Agreement to use highly effective methods of contraception per protocol definitions

    Exclusion Criteria:

    - Prior therapy with alectinib

    - Patients with symptomatic central nervous system (CNS) metastases who are
    neurologically unstable or require increasing doses of steroids within 1 week prior
    to Day 1 to manage CNS symptoms:

    - Patients with brain or leptomeningeal metastases are allowed

    - Symptomatic disease is allowed as long as symptoms are controlled and stable

    - Prior treatment with whole brain radiation or gamma knife must have been completed at
    least 14 days prior to Day 1 and patients must be clinically stable

    - Administration of strong/potent cytochrome P450 3A (CYP3A) inhibitors or inducers,
    except for oral corticosteroids up to 20 mg prednisolone equivalent per day, or
    agents with potential QT prolonging effects within 14 days prior to first
    administration of study drug

    - Liver disease characterized by:

    - Alanine transaminase (ALT) or aspartate aminotransferase (AST) > 3 upper limit of
    normal (ULN) (>/= 5ULN for patients with concurrent liver metastasis) confirmed on
    two consecutive measurements OR

    - Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other
    conditions of decompensated liver disease such as coagulopathy, hepatic
    encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices OR

    - Acute viral or active autoimmune, alcoholic, or other types of hepatitis

    - Any clinically significant concomitant disease or condition that could interfere
    with, or for which the treatment might interfere with, the conduct of the study or
    the absorption of oral medications or that would, in the opinion of the investigator,
    pose an unacceptable risk to the patient in this study

    - Active or uncontrolled infectious diseases requiring treatment

    - History of organ transplant

    - Patients with baseline QTc > 470 ms or patients with symptomatic bradycardia

    - Pregnant or lactating, or intending to become pregnant during the study

    - History of hypersensitivity to any of the additives in alectinib formulation

    - Any psychological, familial, sociological, or geographical condition potentially
    hampering compliance with the study protocol requirements and/or follow-up
    procedures; those conditions should be discussed with the patient before trial entry

    - Serious, uncontrolled infections or current known infection with HIV

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Safety (composite outcome measure): Incidence, nature and severity of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

    Safety (composite outcome measure): Clinically significant changes in vital signs, physical findings, and clinical laboratory results, during and following alectinib administration

    Safety (composite outcome measure): Incidence and reasons for any interruption or premature discontinuation of alectinib

    Safety (composite outcome measure): Incidence and reasons for any dose reductions of alectinib

    Secondary Outcome Measures

    Objective response rate (ORR) (complete response [CR] + partial response [PR]) in patients with measurable disease, based on investigator assessment per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1

    Disease control rate (CR + PR + stable disease [SD]) in patients with measurable disease, based on investigator assessment using RECIST v1.1

    Trial Keywords