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Trial record 20 of 37 for:    ALECTINIB

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

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ClinicalTrials.gov Identifier: NCT02271139
Expanded Access Status : No longer available
First Posted : October 22, 2014
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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
Non-Small Cell Lung Cancer Drug: Alectinib

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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



Intervention Details:
  • Drug: Alectinib
    Alectinib 600 mg administered orally with food.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271139


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

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02271139     History of Changes
Other Study ID Numbers: ML29453
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Disease Progression
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Disease Attributes
Pathologic Processes