Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: Temsirolimus

• Registration Number: NCT01210482
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Implemented as a Drug Use Investigation by Central Registration System

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-14
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1022

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Temsirolimus	Temsirolimus	Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions	96 weeks at maximum	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to TORISEL Injection in a participant who received TORISEL Injection. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening experience (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly. Relatedness to TORISEL Injection was assessed by the physician.
Number of Participants With Adverse Drug Reactions of Major Investigation Items	96 weeks at maximum	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to TORISEL Injection in a participant who received TORISEL Injection. Sixteen events were evaluated as major investigation items, and the result is presented in the table.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	96 weeks maximum	Clinical response was assessed based on the following 4 classes with reference to the "New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) - Japanese Translation JCOG Version:" complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD). The overall response rate, which was defined as the percentage of participants who achieved CR or PR over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% confidence interval.
Response Rate Excluding Participants Evaluated as "Unassessable"	96 weeks maximum	Clinical response was assessed based on the following 4 classes with reference to the "New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) - Japanese Translation JCOG Version:" complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD). The percentage of participants who achieved CR or PR over the total number of assessable effectiveness analysis population excluding those evaluated as "unassessable," was calculated.

Trial Locations

Locations (1)

Kyusyu University Hospital; 🇯🇵 Fukuoka-shi, Fukuoka PREF, Japan