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

Renal Cell Carcinoma Clinical Trial

Official title:

Basis Plan For Postmarketing Survelillances, Etc. Of New Ethical Drugs For Torisel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210482
• Other study ID #: 3066K5-4406
• Secondary ID: B1771015
• Status: Completed
• Start date: August 2010
• Est. completion date: March 2018

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Implemented as a Drug Use Investigation by Central Registration System

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1022
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Temsirolimus
The usual adult dosage is temsirolimus 25 mg once weekly, to be administered via gradual intravenous infusion over 30~60 minutes. The dosage is to be appropriately reduced according to patients' status.

Locations

Country	Name	City	State
Japan	Kyusyu University Hospital	Fukuoka-shi	Fukuoka PREF

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events		24 weeks
Primary	Adverse events not expected from Japanese Package Insert		24 weeks
Primary	Investigation of the incidence status and the risk factors for interstitial lung diseases		24 weeks
Primary	Response rate (Responsive cases: CR, PR, PD, SD)		24 weeks
Secondary	Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items)		24 weeks

External Links

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