Temsirolimus (Torisel) Special Investigation (Regulatory Post Marketing Commitment Plan)
Verified September 2014 by Pfizer
Information provided by (Responsible Party):
First received: August 18, 2011
Last updated: September 8, 2014
Last verified: September 2014
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.
Renal Cell Carcinoma
||Observational Model: Case-Only
Time Perspective: Prospective
||Torisel Special Investigation (Regulatory Post Marketing Commitment Plan)
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- The incidence of adverse events in long-term use [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
- Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
- Among patients registered and treated in the Special Investigation, All-case Survey of Torisel, those continuously treated with Torisel for more than 24 weeks will be included.
- Patients not administered Torisel.
- Patients with a history of severe hypersensitivity to temsirolimus, sirolimus derivative, or any of their components and/or derivatives.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420601
|Contact: Pfizer CT.gov Call Center
|Kinki University Hospital
|Osakasayama, Osaka, Japan |
||Pfizer CT.gov Call Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 18, 2011
||September 8, 2014
||JAPAN:Pharmaceuticals and Medical Devices Agency (PMDA)
Keywords provided by Pfizer:
Regulatory Post Marketing Commitment Plan
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 22, 2014
Carcinoma, Renal Cell
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Physiological Effects of Drugs