Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Pfizer

Status: Completed

Conditions: Renal Cell Carcinoma

Treatments: Drug: Temsirolimus

Study type: Observational

Funder types: Industry

Identifiers

NCT01210482

B1771015 (Other Identifier)

3066K5-4406

Details and patient eligibility

About

The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing:

1. Confirmation of efficacy and safety for medical practice use.
2. Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items).
3. Investigation of the incidence status and the risk factors for interstitial lung diseases.

Full description

Implemented as a Drug Use Investigation by Central Registration System

Enrollment: 1,050 patients

Sex: All

Ages: 15 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).

Exclusion criteria

• Patients not administered Torisel.
• Patients with a history of severe hypersensitivity to temsirolimus, sirolimus derivative, or any of their components and/or derivatives.

Trial design

1,050 participants in 1 patient group

Temsirolimus

Description:

Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma)

Treatment:

Drug: Temsirolimus