A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

Completed · Phase 1/Phase 2

Conditions studied: Non-Small-Cell Lung Carcinoma

In brief

This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.

Key facts

Study ID

NCT01801111

Run by

Hoffmann-La Roche

People needed

138

Starts

2013-06-20

Expected to finish

2017-10-27

Last updated by the study team

2018-11-02

Who can join

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

You may qualify if…

• Locally advanced or metastatic non-small cell lung cancer (stage IIIB or IV by American Joint Committee on Cancer [AJCC])
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Documented ALK rearrangement based on Food and Drug Administration (FDA)-approved test
• Prior treatment with crizotinib and progression according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria. Participants had to have a minimum 1-week wash-out period between the last dose of crizotinib and the first dose of study treatment. Participants can either be chemotherapy-naïve or have received at least one line of platinum-based chemotherapy
• Adequate hematologic, hepatic, and renal function
• Participants with brain or leptomeningeal metastases are allowed if protocol defined criteria are met
• Measurable disease according to RECIST v1.1 prior to administration of first dose of study drug

You may not qualify if…

• Receipt of any other ALK inhibitors in addition to crizotinib
• Receipt of any prior cytotoxic chemotherapy for ALK-positive NSCLC within 4 weeks prior to the first dose of study drug
• Participants who received crizotinib or any other tyrosine kinase inhibitors need to have a minimum 1-week washout period before the first dose of study drug
• Active or uncontrolled infectious diseases requiring treatment
• National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) Grade 3 or higher toxicities due to prior therapy that have not shown improvement and are considered to interfere with current study medication
• History of organ transplant
• Co-administration of anti-cancer therapies other than those administered in this study
• Baseline corrected Q-T interval (QTc) greater than (>) 470 milliseconds, or baseline symptomatic bradycardia (less than 45 heart beats per minute)
• Pregnant or breastfeeding women
• Known Human Immunodeficiency Virus (HIV) positivity or Acquired Immunodeficiency Syndrome (AIDS)-related illness
• History of hypersensitivity to any of the additives in the alectinib formulation
• Any clinically significant concomitant disease or condition that could interfere with, or for which treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in the study

Where it is running

• St. Jude Heritage Healthcare — Fullerton, California, United States
• UC Irvine Medical Center — Orange, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Coastal Integrative Cancer Care — San Luis Obispo, California, United States
• UCLA Cancer Center; Premiere Oncology, A Medical Corporation — Santa Monica, California, United States
• Advanced Medical Specialties — Miami, Florida, United States
• Florida Hospital Cancer Inst — Orlando, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Midwestern Regional Medical Center; Office of Research — Zion, Illinois, United States
• Washington University; Wash Uni. Sch. Of Med — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• Columbia University Medical Center; Department of Hematology/Oncology — New York, New York, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Texas Oncology, P.A. — Dallas, Texas, United States
• Cancer Care Centers of South Texas — San Antonio, Texas, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Prince Charles Hospital — Chermside, Queensland, Australia
• Townsville General Hospital — Douglas, Queensland, Australia
• UZ Antwerpen — Edegem, Belgium
• UZ Gent — Ghent, Belgium
• AZ Delta (Campus Wilgenstraat) — Roeselare, Belgium
• University Hospital Herlev — Herlev, Denmark
• CHU Angers - Hôpital Hôtel Dieu — Angers, France
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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