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

Trial Status: Complete

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.

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

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL

California

La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Lyudmila Alexandrovna Bazhenova
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL

New York

Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: COMPLETED

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: WITHDRAWN

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE
Contact: Jeremy P Cetnar
Phone: 503-494-1080

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Texas

Houston
M D Anderson Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: COMPLETED

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Hoffmann-La Roche

  • Primary ID NP28761
  • Secondary IDs NCI-2014-00009, AF-002JG
  • Clinicaltrials.gov ID NCT01871805