The purpose of this continuation study is to provide continued access to crizotinib treatment for eligible participants from a current Pfizer sponsored crizotinib clinical study that is planned to close.
Eligibility
Sex
ALL
Min age
0 Years
Max age
—
Healthy volunteers
No
Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:
1. Any participant who is receiving crizotinib and deriving clinical benefit (as determined by their doctor) in a Crizotinib Study which is planned to close.
2. Participants must agree to follow the reproductive criteria as outlined in protocol.
3. No ongoing Grade ≥3 or intolerable Grade 2 AEs considered to be related to crizotinib treatment, except for those laboratory eligibility criteria described in Inclusion #4.
4. Adult Participants (≥18 years): Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.
Pediatric Participants (\<18 years): Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.
Exclusion Criteria
Participants with any of the following characteristics/conditions will be excluded:
1. Female participants who are pregnant or breastfeeding.
2. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Primary outcome measure(s)
Number of participants with adverse events leading to permanent discontinuation of study intervention — Baseline up to approximately 5 years Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
Number of serious adverse events reported for all participants — Baseline up to approximately 5 years Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
Trial sites (13)
Facility
City
Region
Status
Cancer Hospital Chinese Academy of Medical Science
Beijing
Beijing Municipality
Beijing Cancer Hospital
Beijing
Beijing Municipality
Fujian Province Oncology Hospital
Fuzhou
Fujian
Sun Yat-Sen University Cancer center
Guangzhou
Guangdong
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou
Guangzhou
Jilin Cancer Hospital
Changchun
Jilin
West China Hospital of Sichuan University
Wuhou District
Sichuan
The First Affiliated Hospital of College of Medicine,Zhejiang University
Hangzhou
Zhejiang
Shanghai Chest Hospital
Shanghai
China
ASST Monza
Monza
MB
National Hospital Organization Nagoya Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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