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Temsirolimus (Torisel) Special Investigation (Regulatory Post Marketing Commitment Plan)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420601
First Posted: August 19, 2011
Last Update Posted: April 4, 2017
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
To confirm the safety of the long-term use of TORISEL 25 mg for Intravenous Drip Infusion particularly for the onset of interstitial lung disease from Weeks 25 to 96 after the start of administration.

Condition Intervention
Renal Cell Carcinoma Drug: Temsirolimus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Torisel 25mg For Intravenous Drip Infusion Special Investigation - Survey On Long-term Use -

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Response rate (Responsive cases: CR, PR, PD, SD) [ Time Frame: 96 weeks ]
  • The onset of interstitial lung disease in long-term use [ Time Frame: 96 weeks ]

Secondary Outcome Measures:
  • The incidence of adverse events in long-term use [ Time Frame: 96 weeks ]

Estimated Enrollment: 120
Actual Study Start Date: September 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Temsirolimus
Among the cases registered and treated in the Special Investigation, All-case Survey of temsirolimus, those continuously treated with temsirolimus for more than 24 weeks will be included.
Drug: Temsirolimus
The usual adult dosage of this drug is 25 mg as temsirolimus once weekly by intravenous drip infusion for 30 to 60 minutes. The dosage may be appropriately reduced, depending on patient condition.
Other Name: Torisel

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

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.


Ages Eligible for Study:   Child, Adult, Senior
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).
  • Among patients registered and treated in the Special Investigation, All-case Survey of Torisel, those continuously treated with Torisel for more than 24 weeks will be included.

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
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): NCT01420601


Locations
Japan
Kinki University Hospital
Osakasayama, Osaka, Japan, 589-8511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01420601     History of Changes
Other Study ID Numbers: B1771016
First Submitted: August 18, 2011
First Posted: August 19, 2011
Last Update Posted: April 4, 2017
Last Verified: April 2017

Keywords provided by Pfizer:
Torisel
Long-term use
Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents