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

September 14, 2018 updated by: Pfizer

Basis Plan For Postmarketing Survelillances, Etc. Of New Ethical Drugs For Torisel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Implemented as a Drug Use Investigation by Central Registration System

Study Type

Observational

Enrollment (Actual)

1022

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Fukuoka PREF
      • Fukuoka-shi, Fukuoka PREF, Japan
        • Kyusyu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Temsirolimus
Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma)
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.
Other Names:
  • Torisel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of adverse events
Time Frame: 24 weeks
24 weeks
Adverse events not expected from Japanese Package Insert
Time Frame: 24 weeks
24 weeks
Investigation of the incidence status and the risk factors for interstitial lung diseases
Time Frame: 24 weeks
24 weeks
Response rate (Responsive cases: CR, PR, PD, SD)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3066K5-4406
  • B1771015 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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