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

• Status: Completed
• Trial end date: 2017-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

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