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Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)

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NCT01597258

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-small Cell Lung Cancer
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

- All the patients whom an investigator prescribes XALKORI. (Patients need to be
administered Crizotinib (XALKORI) in order to be enrolled in this all cases
surveillance.)

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

- Patients not administered XALKORI in spite of enrolled.

NCT01597258
Pfizer
Completed
Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)

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Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
Special Investigation Of Xalkori For Nsclc (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The patients whom an investigator involving A8081031 prescribes the Crizotinib (XALKORI).
Non-small Cell Lung Cancer
Drug: Crizotinib (Xalkori)
XALKORI® Capsule 200 mg?XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "
Other Name: XALKORI® Capsule 200 mg?XALKORI® Capsule 250 mg
Crizotinib (Xalkori)
Intervention: Drug: Crizotinib (Xalkori)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2044
January 2018
January 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.)

Exclusion Criteria:

  • Patients not administered XALKORI in spite of enrolled.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01597258
A8081031
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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