Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

Pfizer

Status and phase: Terminated; Phase 4

Conditions: ALK or ROS1-positive NSCLC

Treatments: Drug: Crizotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03672643

A8081067

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

single arm

Other group

Description:

Crizotinib

Treatment:

Drug: Crizotinib