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

• Status: Withdrawn
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Everolimus; Sirolimus

Criteria

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.