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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 : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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-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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib

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




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: 25 months ]
    All SAEs, and grades 3-5 AEs as assessed by CTCAE v4.03



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672643


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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China, Fujian
Fujian Province Oncology Hospital Recruiting
Fuzhou, Fujian, China, 350014
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510120
China, Jilin
Jilin Provincial Cancer Hospital Recruiting
Changchun, Jilin, China, 130012
China, Sichuan
Sichuan Province Cancer Hospital/Department of Pulmonary Tumor Recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
China
Beijing Cancer Hospital, Internal Department Recruiting
Beijing, China, 100142
Zhongshan Hospital Fudan University Recruiting
Shanghai, China, 200032
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03672643     History of Changes
Other Study ID Numbers: A8081067
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
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

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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:
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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