Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

  • STATUS
    Recruiting
  • End date
    Dec 30, 2026
  • participants needed
    75
  • sponsor
    Pfizer
Updated on 26 January 2021

Summary

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

Description

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.

Details
Condition ALK-positive NSCLC, ALK-positive NSCLC, ALK-positive NSCLC, ALK-positive NSCLC, ALK-positive NSCLC, ALK-positive NSCLC, ALK-positive NSCLC, ALK-positive NSCLC, ALK or ROS1-positive NSCLC, ALK or ROS1-positive NSCLC, ALK or ROS1-positive NSCLC, ALK or ROS1-positive NSCLC, ALK or ROS1-positive NSCLC, ALK or ROS1-positive NSCLC, ALK or ROS1-positive NSCLC
Treatment Crizotinib
Clinical Study IdentifierNCT03672643
SponsorPfizer
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: ALK-positive NSCLC or ALK or ROS1-positive NSCLC?
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
No ongoing NCI CTCAE Grade 3 or intolerable Grade 2 adverse events considered to be related to crizotinib treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0-3
Adequate organ function as defined by the following criteria

Exclusion Criteria

Use of any anticancer drug subsequent to crizotinib prior to study entry
Use of drugs or foods that are known potent Cytochrome P450 (CYP)3A4 inhibitors
Use of drugs that are known potent CYP3A4 inducers
Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices, associated with life threatening arrhythmias
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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