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
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
1 other identifier
expanded_access
N/A
1 country
45
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).
Trial Health
Trial Health Score
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45 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedMarch 9, 2017
March 1, 2017
October 17, 2014
March 7, 2017
Conditions
Interventions
Alectinib 600 mg administered orally with food.
Eligibility Criteria
You may qualify if:
- 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; 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (45)
University of Alabama
Bimingham, Alabama, 35226, United States
Southern Cancer Center
Daphne, Alabama, 36526, United States
Southern Cancer Center
Mobile, Alabama, 36607, United States
Southern Cancer Center - Mobile
Mobile, Alabama, 36608, United States
Southern Cancer Center, PC
Mobile, Alabama, 36608, United States
Lalita Pandit Inc.
Fountain Valley, California, 92708, United States
University of California San Diego Medical Center; Moores Cancer Center
La Jolla, California, 92037, United States
Loma Linda Cancer Center
Loma Linda, California, 92354, United States
LAC USC Medical Center
Los Angeles, California, 90033, United States
University of Southern California
Los Angeles, California, 90033, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
St. Joseph Heritage Healthcare
Sebastopol, California, 95472, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
Loyola University Med Center
Maywood, Illinois, 60153, United States
Investigative Clin Rsch of IN
Indianapolis, Indiana, 46260, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Partners Can Ctr
Boston, Massachusetts, 02115-6084, United States
Beth Israel Deaconess Med Ctr; Hem/Onc
Boston, Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Henry Ford Health System
West Bloomfield, Michigan, 48322, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Comprehensive Cancer Care, P.C.
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center; Billings Cancer Research
Billings, Montana, 59101, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Columbia University Medical Center; Clinical Research Management Office
New York, New York, 10032, United States
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina, United States
Mark H. Zangmeister Center
Columbus, Ohio, 43219, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146, United States
Oregon Health & Science Uni
Portland, Oregon, 97239, United States
Forbes Hospital
Monroeville, Pennsylvania, 15146, United States
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, 15065, United States
Cancer Treatment Centers of America - Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212, United States
West Penn Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina; Hollings Cancer Center
Charleston, South Carolina, 29425, United States
UT Southwestern Medical Center
Dallas, Texas, 75390-8813, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98195, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
University of Wisconsin; Oncology
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 39661917DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2014
First Posted
October 22, 2014
Last Updated
March 9, 2017
Record last verified: 2017-03