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

Completed · Phase 1/Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01871805

Run by

Hoffmann-La Roche

People needed

134

Starts

2013-09-30

Expected to finish

2017-08-31

Last updated by the study team

2018-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California Irvine — Irvine, California, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• Loma Linda Cancer Center — Loma Linda, California, United States
• UCLA — Los Angeles, California, United States
• Univ of Colorado Canc Ctr — Aurora, Colorado, United States
• National Jewish Health — Denver, Colorado, United States
• Lynn Regional Cancer Center West — Boca Raton, Florida, United States
• Florida Hospital Cancer Inst — Orlando, Florida, United States
• UF Health Orlando — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center and Research Inst. — Tampa, Florida, United States
• University of Illinois Cancer Center — Chicago, Illinois, United States
• Monroe Medical Associates; Ingalls Memorial Hosp — Harvey, Illinois, United States
• Massachussets General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Can Ins — Boston, Massachusetts, United States
• Newton-Wellesley Hospital — Newton, Massachusetts, United States
• St. Joseph Mercy Hospital; Cancer Care Center. — Ann Arbor, Michigan, United States
• Wayne State Uni ; Karmanos Cancer Center — Detroit, Michigan, United States
• Hackensack Univ Med Ctr — Hackensack, New Jersey, United States
• Roswell Park Cancer Inst. — Buffalo, New York, United States
• Memorial Sloan-Kettering Cancer Center — Commack, New York, United States
• Richmond University Medical Center; Pharmacy Department — Staten Island, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States

Full record on ClinicalTrials.gov

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