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

NCT01781442 | Withdrawn DMC

• 1 other identifier: B1771110
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Cell Carcinoma

Keywords

Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs]

  2 years

Study Arms (1)

Patient Arm- temsirolimus

Drug: Temsirolimus

Interventions

Temsirolimus DRUG

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.

Patient Arm- temsirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 1, 2013

Record last verified: 2013-04