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Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03672643
Collaborator
(none)
41
Enrollment
10
Locations
1
Arm
95
Anticipated Duration (Months)
4.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

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
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
Actual Enrollment :
41 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
single arm, open label study.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 :
Jan 28, 2019
Anticipated Primary Completion Date :
Dec 30, 2026
Anticipated Study Completion Date :
Dec 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: single arm

Crizotinib

Drug: Crizotinib
receive crizotinib orally
Other Names:
  • 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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Fujian Province Oncology Hospital Fuzhou Fujian China 350014
    2 The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510120
    3 General Hospital of Eastern Command Nanjing Jiangsu China 210002
    4 Jilin Provincial Cancer Hospital Changchun Jilin China 130012
    5 Shanghai Chest Hospital Shanghai Shanghai China 200030
    6 Sichuan Province Cancer Hospital/Department of Pulmonary Tumor Chengdu Sichuan China 610041
    7 West China Hospital of Sichuan University Chengdu Sichuan China 610041
    8 Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University Hangzhou Zhejiang China 310003
    9 Beijing Cancer Hospital, Internal Department Beijing China 100142
    10 Zhongshan Hospital Fudan University Shanghai China 200032

    Sponsors and Collaborators

    • Pfizer

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT03672643
    Other Study ID Numbers:
    • A8081067
    First Posted:
    Sep 14, 2018
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Crizotinib

    Study Results

    No Results Posted as of Jan 24, 2022