Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

NCT03672643

Last updated date
Study Location
Nanjing Bayi Hospital of PLA
Nanjing, Jiangsu, 210002, China
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ALK or ROS1-positive NSCLC
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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ALK or ROS1-positive NSCLCLong Term Safety Observation of Crizotinib in Chinese NSCLC Population
NCT03672643
  1. Nanjing, Jiangsu
  2. Fuzhou, Fujian
  3. Guangzhou, Guangdong
  4. Changchun, Jilin
  5. Shanghai, Shanghai
  6. Shanghai, Shanghai
  7. Chengdu, Sichuan
  8. Chengdu, Sichuan
  9. Hangzhou, Zhejiang
  10. Beijing,
  11. Shanghai,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Center1-800-718-1021[email protected]
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/d….
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/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2020

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