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

Pfizer1,050 enrolled

Overview

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.

Implemented as a Drug Use Investigation by Central Registration System

Study Type

OBSERVATIONAL

Enrollment

1,050

Conditions

Renal Cell Carcinoma

Interventions

TemsirolimusDRUG

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.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kyusyu University Hospital

Fukuoka, Fukuoka PREF, Japan

Outcomes

Primary Outcomes

Number of Participants With Adverse Drug Reactions

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.

Time frame: 96 weeks at maximum

Number of Participants With Adverse Drug Reactions of Major Investigation Items

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.

Time frame: 96 weeks at maximum

Secondary Outcomes

Overall Response Rate

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.

Time frame: 96 weeks maximum

Response Rate Excluding Participants Evaluated as "Unassessable"

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.

Data from ClinicalTrials.gov

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