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Brief Title: A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
Official Title: A Phase I/II Study of the ALK Inhibitor CH5424802/ RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated With Crizotinib
Study ID: NCT01871805
Brief Summary: This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of alectinib in participants with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment. In Phase I, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Phase II, patients who failed crizotinib treatment will receive the recommended phase II dose.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of California Irvine, Irvine, California, United States
UCSD Moores Cancer Center, La Jolla, California, United States
Loma Linda Cancer Center, Loma Linda, California, United States
UCLA, Los Angeles, California, United States
Univ of Colorado Canc Ctr, Aurora, Colorado, United States
National Jewish Health, Denver, Colorado, United States
Lynn Regional Cancer Center West, Boca Raton, Florida, United States
Florida Hospital Cancer Inst, Orlando, Florida, United States
UF Health Orlando, Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Inst., Tampa, Florida, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Monroe Medical Associates; Ingalls Memorial Hosp, Harvey, Illinois, United States
Massachussets General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Can Ins, Boston, Massachusetts, United States
Newton-Wellesley Hospital, Newton, Massachusetts, United States
St. Joseph Mercy Hospital; Cancer Care Center., Ann Arbor, Michigan, United States
Wayne State Uni ; Karmanos Cancer Center, Detroit, Michigan, United States
Hackensack Univ Med Ctr, Hackensack, New Jersey, United States
Roswell Park Cancer Inst., Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center, Commack, New York, United States
Richmond University Medical Center; Pharmacy Department, Staten Island, New York, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Providence Portland Med Ctr, Portland, Oregon, United States
Oregon Health & Science Uni, Portland, Oregon, United States
St. Luke's Hospital; Pharmacy Department, Bethlehem, Pennsylvania, United States
Penn State Hershey Cancer Institute, Hershey, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Pavillion, Pittsburgh, Pennsylvania, United States
MUSC Hollings Cancer Center, Charleston, South Carolina, United States
Center for Biomedical Research LLC, Knoxville, Tennessee, United States
Texas Oncology-Baylor Sammons Cancer Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Swedish Cancer Inst., Seattle, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Lakeridge Health Oshawa; Oncology, Oshawa, Ontario, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR