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
NCT ID: NCT02271139
Last Updated: 2017-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Alectinib
Alectinib 600 mg administered orally with food.
Eligibility Criteria
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Inclusion Criteria
* 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; 2) 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
* 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)
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama
Bimingham, Alabama, United States
Southern Cancer Center
Daphne, Alabama, United States
Southern Cancer Center
Mobile, Alabama, United States
Southern Cancer Center - Mobile
Mobile, Alabama, United States
Southern Cancer Center, PC
Mobile, Alabama, United States
Lalita Pandit Inc.
Fountain Valley, California, United States
University of California San Diego Medical Center; Moores Cancer Center
La Jolla, California, United States
Loma Linda Cancer Center
Loma Linda, California, United States
LAC USC Medical Center
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States
St. Joseph Heritage Healthcare
Sebastopol, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Hospital
Chicago, Illinois, United States
Loyola University Med Center
Maywood, Illinois, United States
Investigative Clin Rsch of IN
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Partners Can Ctr
Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr; Hem/Onc
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Henry Ford Health System
West Bloomfield, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Comprehensive Cancer Care, P.C.
St Louis, Missouri, United States
Billings Clinic Cancer Center; Billings Cancer Research
Billings, Montana, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Columbia University Medical Center; Clinical Research Management Office
New York, New York, United States
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina, United States
Mark H. Zangmeister Center
Columbus, Ohio, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, United States
Oregon Health & Science Uni
Portland, Oregon, United States
Forbes Hospital
Monroeville, Pennsylvania, United States
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, United States
Cancer Treatment Centers of America - Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
West Penn Cancer Institute
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina; Hollings Cancer Center
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
University of Wisconsin; Oncology
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Sikkema BJ, Baart SJ, Paats MS, Smit EF, Schols AMWJ, Mathijssen RHJ, van Rossum EFC, Dingemans AC. Body Weight Gain Associated With Alectinib in Patients With ALK+ Non-Small Cell Lung Cancer: Pooled Analysis of Individual Patient Data From Four Prospective Clinical Trials. J Clin Oncol. 2025 Feb 20;43(6):641-650. doi: 10.1200/JCO-24-01579. Epub 2024 Dec 11.
Other Identifiers
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ML29453
Identifier Type: -
Identifier Source: org_study_id
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