Safety And Efficacy Of Crizotinib (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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Special Investigation Of Xalkori For NSCLC (Regulatory Post Marketing Commitment Plan)|
- The incidence of adverse drug reactions in this surveillance. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- Objective Response Rate (ORR) at 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2019 (Final data collection date for primary outcome measure)|
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
All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597258
|Study Director:||Pfizer CT.gov Call Center||Pfizer|