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Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Beijing Cancer Hospital
Beijing, , China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ALK-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

NCT03672643
Pfizer
Not yet recruiting
Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

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Long Term Safety Observation of Crizotinib in Chinese NSCLC Population
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)
This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Intervention Model Description:
single arm, open label study.

Masking: None (Open Label)
Primary Purpose: Treatment

ALK-positive NSCLC
Drug: Crizotinib
receive crizotinib orally
Other Name: Xalkori
single arm
Crizotinib
Intervention: Drug: Crizotinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
75
Same as current
June 4, 2022
June 4, 2022   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
China
 
 
NCT03672643
A8081067
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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