Lung Cancer Clinical Trial
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
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.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic NSCLC
ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test
NSCLC that has failed crizotinib treatment
Measurable disease as defined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2
Adequate hematologic, hepatic and renal function
Exclusion Criteria:
Prior therapy with ALK inhibitor other than crizotinib
Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment
History of serious cardiac dysfunction
History of or current active infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
Clinically significant gastrointestinal abnormality that would affect absorption of the drug
Pregnant or lactating women
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There are 41 Locations for this study
Birmingham Alabama, 35233, United States
Irvine California, 92697, United States
La Jolla California, 92093, United States
Loma Linda California, 92354, United States
Los Angeles California, 90095, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80206, United States
Boca Raton Florida, 33486, United States
Orlando Florida, 32804, United States
Orlando Florida, 32806, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60612, United States
Harvey Illinois, 60426, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Newton Massachusetts, 02462, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48201, United States
Hackensack New Jersey, 07601, United States
Buffalo New York, 14263, United States
Commack New York, 11725, United States
Staten Island New York, 10310, United States
Winston-Salem North Carolina, 27157, United States
Canton Ohio, 44718, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97239, United States
Bethlehem Pennsylvania, 18015, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Charleston South Carolina, 29425, United States
Knoxville Tennessee, 37909, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98104, United States
Madison Wisconsin, 53792, United States
Edmonton Alberta, T6G 1, Canada
Oshawa Ontario, L1G 2, Canada
Montreal Quebec, H3T 1, Canada
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