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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01781442
• Other study ID #: B1771110
• Status: Withdrawn
• Phase: Phase 4
• First received: January 30, 2013
• Last updated: April 30, 2013
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: April 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines : Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Temsirolimus
The recommended dose of Torisel is 25 mg infused over a 30-60 minute period once a week. Treatment will continue until disease progression or unacceptable toxicity. The use and dosage recommendations for Torisel will take place on the basis of the approved local product document and will be adjusted solely according to medical and therapeutic necessity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs]		2 years	Yes

External Links

•   To obtain contact information for a study center near you, click here.