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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01420601
Other study ID # B1771016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2011
Est. completion date March 2018

Study information

Verified date September 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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