Torisel Special Investigation (Regulatory Post Marketing Commitment Plan)
Phase 4
N/A
N/A
N/A
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma
Both
Renal Cell Carcinoma
Trial Information
Torisel Special Investigation (Regulatory Post Marketing Commitment Plan)
Implemented as a Drug Use Investigation by Central Registration System
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients not administered Torisel.
- Patients with a history of severe hypersensitivity to temsirolimus, sirolimus
derivative, or any of their components and/or derivatives.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Response rate (Responsive cases: CR, PR, PD, SD)
Outcome Time Frame:
96 weeks
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
JAPAN:Pharmaceuticals and Medical Devices Agency (PMDA)
Study ID:
B1771016
NCT ID:
NCT01420601
Start Date:
September 2011
Completion Date:
August 2015
Related Keywords:
- Renal Cell Carcinoma
- Torisel
- Long-term use
- Regulatory Post Marketing Commitment Plan
- Carcinoma
- Carcinoma, Renal Cell
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