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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01781442
First received: January 30, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Renal Cell Carcinoma
Drug: Temsirolimus
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs] [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient Arm- temsirolimus 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781442

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01781442     History of Changes
Other Study ID Numbers: B1771110
Study First Received: January 30, 2013
Last Updated: April 30, 2013
Health Authority: Philippines : Food and Drug Administration

Keywords provided by Pfizer:
Metastatic Renal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014