Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01210482
Recruitment Status : Completed
First Posted : September 28, 2010
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Renal Cell Carcinoma Drug: Temsirolimus

Detailed Description:
Implemented as a Drug Use Investigation by Central Registration System

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 1022 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Torisel


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The incidence of adverse events [ Time Frame: 24 weeks ]
  2. Adverse events not expected from Japanese Package Insert [ Time Frame: 24 weeks ]
  3. Investigation of the incidence status and the risk factors for interstitial lung diseases [ Time Frame: 24 weeks ]
  4. Response rate (Responsive cases: CR, PR, PD, SD) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items) [ Time Frame: 24 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Japan
Kyusyu University Hospital
Fukuoka-shi, Fukuoka PREF, Japan
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01210482     History of Changes
Obsolete Identifiers: NCT01420601
Other Study ID Numbers: 3066K5-4406
B1771015 ( Other Identifier: Alias Study Number )
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Keywords provided by Pfizer:
Torisel
Regulatory Post Marketing Commitment Plan
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents