Status:
COMPLETED
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT01871805
Start Date
September 30 2013
End Date
August 31 2017
Last Update
August 21 2018
Active Locations (42)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California Irvine
Irvine, California, United States, 92697
3
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
4
Loma Linda Cancer Center
Loma Linda, California, United States, 92354