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

• ClinicalTrials.gov Identifier: NCT01781442
• Recruitment Status: Withdrawn
• First Posted: February 1, 2013
• Last Update Posted: May 1, 2013
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 30, 2013
• First Posted Date: February 1, 2013
• Last Update Posted Date: May 1, 2013
• Study Start Date: June 2013
• Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 30, 2013): Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs] [ Time Frame: 2 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: January 30, 2013): No secondary outcomes [ Time Frame: No secondary outcomes ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Post Marketing Surveillance As Required By Philippine Food And Drug Administration
• 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
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: This is a prospective observational, non-interventional study which will evaluate Torisel in Filipino adult subjects. Because the data to be collected will be under routine clinical conditions, subjects who have any of the contraindications specified in the product package insert are to be excluded. Torisel will be prescribed and administered according to the approved product information of the drug in the Philippines. Pfizer will not provide the drug for this study.
• Condition: 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.

Study Groups/Cohorts

Patient Arm- temsirolimus

Intervention: Drug: Temsirolimus

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: April 30, 2013): 0
• Original Estimated Enrollment (submitted: January 30, 2013): 20
• Estimated Study Completion Date: June 2015
• Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01781442
• Other Study ID Numbers: B1771110
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2013