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

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).

Study Overview

• Status: No longer available
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Alectinib

• Study Type: Expanded Access

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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; 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:

• 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)

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 22, 2014

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Disease Progression; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ML29453

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No