Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
This study is a phase 4 study, to continually access Xalkori to Chinese patients who were recruited in previous studies of Crizotinib in China, and only collect the safety data.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Long Term Safety Observation of Crizotinib in Chinese NSCLC Population
