Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
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|ClinicalTrials.gov Identifier: NCT01210482|
Recruitment Status : Completed
First Posted : September 28, 2010
Last Update Posted : September 17, 2018
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|
|Actual Enrollment :||1022 participants|
|Official Title:||Basis Plan For Postmarketing Survelillances, Etc. Of New Ethical Drugs For Torisel|
|Actual Study Start Date :||August 2010|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|