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Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

Last updated on February 20, 2019

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Study Location
Beijing Cancer Hospital
Beijing, , China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ALK-positive NSCLC
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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

NCT03672643
Pfizer
Not yet recruiting
Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

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Pfizer Clinical Trials Contact Center

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[email protected]

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ALK-positive NSCLC
NCT03672643
All Genders
18+
Years
Multiple Sites

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]

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