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Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

NCT03672643

TerminatedPhase 4

Sponsor: Pfizer

Conditions: ALK or ROS1-positive NSCLC

Interventions: Crizotinib

Countries: China

This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Patients who were enrolled and treated in Studies A8081005, A8081007, A8081014, A8081029, or A8081063 and are still receiving crizotinib treatment at the time of enrollment into this study. OR Patients randomized to the chemotherapy arm in Studies A8081014 or A8081029 who have experienced investigator assessed disease progression and have not yet crossed over to receive crizotinib treatment.
2. No ongoing NCI CTCAE Grade 3 or intolerable Grade 2 adverse events considered to be related to crizotinib treatment
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
4. Adequate organ function as defined by the following criteria

Exclusion Criteria:

1. Use of any anticancer drug subsequent to crizotinib prior to study entry
2. Use of drugs or foods that are known potent Cytochrome P450 (CYP)3A4 inhibitors
3. Use of drugs that are known potent CYP3A4 inducers
4. Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices, associated with life threatening arrhythmias

Locations (14)

Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Liwan District,Guangzhou, Guangdong, China
Nanjing, Jiangsu, China
Changchun, Jilin, China
Changchun, Jilin, China
Shanghai, Shanghai Municipality, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Beijing, China
Shanghai, China