Temsirolimus (Torisel) Special Investigation (Regulatory Post Marketing Commitment Plan)
To confirm the safety of the long-term use of TORISEL 25 mg for Intravenous Drip Infusion particularly for the onset of interstitial lung disease from Weeks 25 to 96 after the start of administration.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Torisel Special Investigation (Regulatory Post Marketing Commitment Plan)|
- Response rate (Responsive cases: CR, PR, PD, SD) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- The onset of interstitial lung disease in long-term use [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
- The incidence of adverse events in long-term use [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Among the cases registered and treated in the Special Investigation, All-case Survey of temsirolimus, those continuously treated with temsirolimus for more than 24 weeks will be included.
The usual adult dosage of this drug is 25 mg as temsirolimus once weekly by intravenous drip infusion for 30 to 60 minutes. The dosage may be appropriately reduced, depending on patient condition.
Other Name: Torisel
Implemented as a Drug Use Investigation by Central Registration System
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420601
|Contact: Pfizer CT.gov Call Center||1-800-718-1021|
|Kinki University Hospital||Recruiting|
|Osakasayama, Osaka, Japan|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|