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

March 7, 2017 updated by: Genentech, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2022

Primary Completion

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2022

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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