A Post Marketing Surveillance As Required By Philippine Food And Drug Administration

Withdrawn

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: Temsirolimus

• Registration Number: NCT01781442
• Lead Sponsor: Pfizer

Brief Summary

This is a post marketing surveillance which determines the safety profile of the product to Filipinos. This is a FDA requirement for registration.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-30
• Last Update Posted: 2013-05-01
• Study Start: 2013-06
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Arm- temsirolimus	Temsirolimus	-

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs]	2 years