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Trial record 1 of 1 for:    NCT03672643
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Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

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ClinicalTrials.gov Identifier: NCT03672643
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 19, 2018
First Posted Date  ICMJE September 14, 2018
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE January 28, 2019
Estimated Primary Completion Date December 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
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: 25 months ]
All SAEs, and grades 3-5 AEs as assessed by CTCAE v4.03
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Safety Observation of Crizotinib in Chinese NSCLC Population
Official Title  ICMJE 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)
Brief Summary This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
single arm, open label study.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ALK or ROS1-positive NSCLC
Intervention  ICMJE Drug: Crizotinib
receive crizotinib orally
Other Name: Xalkori
Study Arms  ICMJE single arm
Crizotinib
Intervention: Drug: Crizotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2026
Estimated Primary Completion Date December 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03672643
Other Study ID Numbers  ICMJE A8081067
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP