Temsirolimus (Torisel) Special Investigation (Regulatory Post Marketing Commitment Plan)

Renal Cell Carcinoma Clinical Trial

Official title:

Torisel 25mg For Intravenous Drip Infusion Special Investigation - Survey On Long-term Use -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420601
• Other study ID #: B1771016
• Status: Completed
• Start date: September 2011
• 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

To confirm the safety of the long-term use of TORISEL 25 mg for Intravenous Drip Infusion particularly for the onset of interstitial lung disease from Weeks 25 to 96 after the start of administration.

Description:

Implemented as a Drug Use Investigation by Central Registration System

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Among patients registered and treated in the Special Investigation, All-case Survey of Torisel, those continuously treated with Torisel for more than 24 weeks will be included.

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 of this drug is 25 mg as temsirolimus once weekly by intravenous drip infusion for 30 to 60 minutes. The dosage may be appropriately reduced, depending on patient condition.

Locations

Country	Name	City	State
Japan	Kinki University Hospital	Osakasayama	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (Responsive cases: CR, PR, PD, SD)		96 weeks
Primary	The onset of interstitial lung disease in long-term use		96 weeks
Secondary	The incidence of adverse events in long-term use		96 weeks

External Links

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