Spots Global Cancer Trial Database for 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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Trial Identification
Brief Title: 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
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
Study ID: NCT02271139
Conditions
Interventions
Study Description
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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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