Status:
COMPLETED
A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 crizot...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2017
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT01801111
Start Date
June 20 2013
End Date
October 27 2017
Last Update
November 2 2018
Active Locations (84)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
3
UC Irvine Medical Center
Orange, California, United States, 92868
4
Sharp Memorial Hospital
San Diego, California, United States, 92123