Special Investigation Of Xalkori For NSCLC (Regulatory Post Marketing Commitment Plan)
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Non-small Cell Lung Cancer
Both
Non-small Cell Lung Cancer
Trial Information
Special Investigation Of Xalkori For NSCLC (Regulatory Post Marketing Commitment Plan)
All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
The incidence of adverse drug reactions in this surveillance.
Outcome Time Frame:
52 weeks
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
A8081031
NCT ID:
NCT01597258
Start Date:
May 2012
Completion Date:
November 2017
Related Keywords:
- Non-Small Cell Lung Cancer
- Safety
- All cases surveillance in Japan
- ALK-positive unresectable advanced and/or recurrent non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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