A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
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.
Checked against the public recordLast updated Aug 21, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Hoffmann-La Roche
- Interventions being studied
- Drug: Alectinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at BirminghamBirmingham, Alabama
- University of California IrvineIrvine, California
- UCSD Moores Cancer CenterLa Jolla, California
- Loma Linda Cancer CenterLoma Linda, California
- UCLALos Angeles, California
- Univ of Colorado Canc CtrAurora, Colorado
- National Jewish HealthDenver, Colorado
- Lynn Regional Cancer Center WestBoca Raton, Florida
- Florida Hospital Cancer InstOrlando, Florida
- UF Health OrlandoOrlando, Florida
- H. Lee Moffitt Cancer Center and Research Inst.Tampa, Florida
- University of Illinois Cancer CenterChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2018. Always confirm current availability with the study team.