Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

• ClinicalTrials.gov Identifier: NCT03672643
• Recruitment Status: Active, not recruiting
• First Posted: September 14, 2018
• Last Update Posted: January 24, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
ALK or ROS1-positive NSCLC	Drug: Crizotinib	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: single arm, open label study.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: January 28, 2019
• Estimated Primary Completion Date: December 30, 2026
• Estimated Study Completion Date: December 30, 2026

Arms and Interventions

Arm	Intervention/treatment
single arm; Crizotinib	Drug: Crizotinib; receive crizotinib orally; Other Name: Xalkori

Outcome Measures

Primary Outcome Measures :

1. long term safety of crizotinnib in patients with advanced NSCLC harboring a translocation or inversion of the ALK gene or ROS1 gene locus [ Time Frame: Baseline up to 7 years ]
   All SAEs，all AEs leading to permanent treatment discontinuation, and all grades 3-5 AEs as assessed by CTCAE v4.03

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Fujian

Fujian Province Oncology Hospital

Fuzhou, Fujian, China, 350014

China, Guangdong

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510120

China, Jiangsu

General Hospital of Eastern Command

Nanjing, Jiangsu, China, 210002

China, Jilin

Jilin Provincial Cancer Hospital

Changchun, Jilin, China, 130012

China, Shanghai

Shanghai Chest Hospital

Shanghai, Shanghai, China, 200030

China, Sichuan

Sichuan Province Cancer Hospital/Department of Pulmonary Tumor

Chengdu, Sichuan, China, 610041

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

China, Zhejiang

Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310003

China

Beijing Cancer Hospital, Internal Department

Beijing, China, 100142

Zhongshan Hospital Fudan University

Shanghai, China, 200032

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03672643
• Other Study ID Numbers: A8081067
• First Posted: September 14, 2018
• Last Update Posted: January 24, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

NSCLC

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Crizotinib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action