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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01210482
Other study ID # 3066K5-4406
Secondary ID B1771015
Status Completed
Phase
First received
Last updated
Start date August 2010
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

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.

Study Design


Related Conditions & MeSH terms


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
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