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A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

NCT01871805

CompletedPhase 1, Phase 2

Sponsor: Hoffmann-La Roche

Conditions: Non-Small Cell Lung Cancer

Interventions: Alectinib

Countries: United States, Canada

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (42)

Birmingham, Alabama, United States
Irvine, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Boca Raton, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Harvey, Illinois, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Newton, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Hackensack, New Jersey, United States
Buffalo, New York, United States
Commack, New York, United States
Staten Island, New York, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Hershey, Pennsylvania, United States
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