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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01781442

Enrollment

Registered

2013-02-01

Start date

2013-06-30

Completion date

2015-06-30

Last updated

2013-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

Metastatic Renal Cell Carcinoma

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.

Interventions

DRUGTemsirolimus

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs]	2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026