An Open Label, Non-interventional Study Of The Safety Of Temsirolimus Injection (Torisel) In The Treatment Of Advanced Renal Cell Carcinoma In Filipino Adult Patients: A Post Marketing Surveillance Study
18 Years
N/A
Both
Renal Cell Carcinoma
Trial Information
An Open Label, Non-interventional Study Of The Safety Of Temsirolimus Injection (Torisel) In The Treatment Of Advanced Renal Cell Carcinoma In Filipino Adult Patients: A Post Marketing Surveillance Study
The Philippine Food and Drug Administration requires that a post marketing surveillance
study be conducted nationwide and enroll approximately 3,000 study patients. In cases where
the 3,000 patients will not be met, the total sample size can be reduced to 10% of the
volume of drug use during the first year of it being marketed. Final sample size will be
determined after one year of marketing authorization. The decision to use Torisel must be a
joint decision made by the subject and the investigator.
The investigator must discuss product information with the subject as per usual practice.
Inclusion Criteria:
- Subjects that will be included in this post marketing surveillance study must be
consistent with the approved label indication of Torisel in the Philippines.
- As per approved label indication, patients diagnosed with advanced renal cell
carcinoma will be the ones eligible to participate in the study.
- The decision to prescribe Torisel will necessarily precede and will be independent of
the decision to enroll the patient into the study.
- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.
Exclusion Criteria:
- Subjects with conditions that are contraindicated with Torisel based on the approved
local product document in the Philippines will be excluded in this study. This
condition includes: Patients with bilirubin >1.5 x ULN.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs]
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Philippines : Food and Drug Administration
Study ID:
B1771110
NCT ID:
NCT01781442
Start Date:
June 2013
Completion Date:
June 2015
Related Keywords:
- Renal Cell Carcinoma
- Metastatic Renal Cell Carcinoma
- Carcinoma
- Carcinoma, Renal Cell
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