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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

Sponsor
Genentech, Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT02271139
Collaborator
(none)
45
Locations

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants 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: 1) participants 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;

    1. participants must have recovered from treatment toxicities to less than or equal to (</=) Grade 1 or to their pretreatment levels (for participants who have developed interstitial lung disease [ILD], they must have fully recovered); 3) participants can either be chemotherapy-naïve 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

    • Participants 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

    • Administration of strong/potent cytochrome P450 3A (CYP3A) inhibitors or inducers, or agents with potential QT prolonging effects within 14 days prior to first administration of study drug

    • Participants with liver disease

    • Any clinically significant concomitant disease or condition that could interfere with the conduct of the study

    • Active or uncontrolled infectious diseases requiring treatment

    • History of organ transplant

    • Participants with baseline QTc > 470 milliseconds (ms) or participants 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 participants before trial entry

    • Serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Bimingham Alabama United States 35226
    2 Southern Cancer Center Daphne Alabama United States 36526
    3 Southern Cancer Center Mobile Alabama United States 36607
    4 Southern Cancer Center - Mobile Mobile Alabama United States 36608
    5 Southern Cancer Center, PC Mobile Alabama United States 36608
    6 Lalita Pandit Inc. Fountain Valley California United States 92708
    7 University of California San Diego Medical Center; Moores Cancer Center La Jolla California United States 92037
    8 Loma Linda Cancer Center Loma Linda California United States 92354
    9 LAC USC Medical Center Los Angeles California United States 90033
    10 University of Southern California Los Angeles California United States 90033
    11 University of California Irvine Medical Center Orange California United States 92868
    12 St. Joseph Heritage Healthcare Sebastopol California United States 95472
    13 Innovative Clinical Research Institute Whittier California United States 90603
    14 University Cancer & Blood Center, LLC Athens Georgia United States 30607
    15 Northwestern University Chicago Illinois United States 60611
    16 University of Chicago Hospital Chicago Illinois United States 60637
    17 Loyola University Med Center Maywood Illinois United States 60153
    18 Investigative Clin Rsch of IN Indianapolis Indiana United States 46260
    19 Massachusetts General Hospital Boston Massachusetts United States 02114
    20 Dana Farber Partners Can Ctr Boston Massachusetts United States 02115-6084
    21 Beth Israel Deaconess Med Ctr; Hem/Onc Boston Massachusetts United States 02215
    22 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    23 Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
    24 Henry Ford Health System West Bloomfield Michigan United States 48322
    25 University of Minnesota Minneapolis Minnesota United States 55455
    26 Comprehensive Cancer Care, P.C. St. Louis Missouri United States 63141
    27 Billings Clinic Cancer Center; Billings Cancer Research Billings Montana United States 59101
    28 San Juan Oncology Associates Farmington New Mexico United States 87401
    29 Columbia University Medical Center; Clinical Research Management Office New York New York United States 10032
    30 W.G. Bill Hefner VA Medical Center Salisbury North Carolina United States
    31 Mark H. Zangmeister Center Columbus Ohio United States 43219
    32 Tulsa Cancer Institute Tulsa Oklahoma United States 74146
    33 Oregon Health & Science Uni Portland Oregon United States 97239
    34 Forbes Hospital Monroeville Pennsylvania United States 15146
    35 Allegheny Valley Hospital Natrona Heights Pennsylvania United States 15065
    36 Cancer Treatment Centers of America - Eastern Regional Medical Center Philadelphia Pennsylvania United States 19124
    37 Allegheny Cancer Center Pittsburgh Pennsylvania United States 15212
    38 West Penn Cancer Institute Pittsburgh Pennsylvania United States 15224
    39 Medical University of South Carolina; Hollings Cancer Center Charleston South Carolina United States 29425
    40 UT Southwestern Medical Center Dallas Texas United States 75390-8813
    41 Virginia Cancer Specialists, PC Fairfax Virginia United States 22031
    42 University of Washington Seattle Cancer Care Alliance Seattle Washington United States 98195
    43 Northwest Medical Specialties Tacoma Washington United States 98405
    44 University of Wisconsin; Oncology Madison Wisconsin United States 53792
    45 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Genentech, Inc.

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT02271139
    Other Study ID Numbers:
    • ML29453
    First Posted:
    Oct 22, 2014
    Last Update Posted:
    Mar 9, 2017
    Last Verified:
    Mar 1, 2017
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Disease Progression

    Study Results

    No Results Posted as of Mar 9, 2017