Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
|ClinicalTrials.gov Identifier: NCT01210482|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2010
Last Update Posted : April 5, 2017
The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing:
- Confirmation of efficacy and safety for medical practice use.
- Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items).
- Investigation of the incidence status and the risk factors for interstitial lung diseases.
|Condition or disease||Intervention/treatment|
|Renal Cell Carcinoma||Drug: Temsirolimus|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Basis Plan For Postmarketing Survelillances, Etc. Of New Ethical Drugs For Torisel|
|Actual Study Start Date :||August 2010|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma)
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.
Other Name: Torisel
- The incidence of adverse events [ Time Frame: 24 weeks ]
- Adverse events not expected from Japanese Package Insert [ Time Frame: 24 weeks ]
- Investigation of the incidence status and the risk factors for interstitial lung diseases [ Time Frame: 24 weeks ]
- Response rate (Responsive cases: CR, PR, PD, SD) [ Time Frame: 24 weeks ]
- Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items) [ Time Frame: 24 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210482
|Kyusyu University Hospital|
|Fukuoka-shi, Fukuoka Pref, Japan|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|