Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

ALK or ROS1-positive NSCLC Clinical Trial

Official title:

AN OPEN-LABEL, SINGLE-ARM STUDY OF THE LONG-TERM SAFETY OF XALKORI (REGISTERED) IN PATIENTS FROM CHINA WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) OR ROS1 LOCUS WHO HAVE PREVIOUSLY BEEN TREATED ON A STUDY OF XALKORI (REGISTERED)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03672643
• Other study ID #: A8081067
• Status: Terminated
• Phase: Phase 4
• Start date: January 28, 2019
• Est. completion date: September 28, 2023

Study information

• Verified date: October 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALK or ROS1-positive NSCLC
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Crizotinib
receive crizotinib orally

Locations

Country	Name	City	State
China	Beijing Cancer Hospital, Internal Department	Beijing
China	Jilin Provincial Cancer Hospital	Changchun	Jilin
China	Sichuan Province Cancer Hospital/Department of Pulmonary Tumor	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Fujian Province Oncology Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	General Hospital of Eastern Command	Nanjing	Jiangsu
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long term safety of crizotinib in patients with advanced NSCLC harboring a translocation or inversion of the ALK gene or ROS1 gene locus	All SAEs,all AEs leading to permanent treatment discontinuation, and all grades 3-5 AEs as assessed by CTCAE v4.03	Baseline up to 7 years

External Links

•   To obtain contact information for a study center near you, click here.