Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01420601
First received: August 18, 2011
Last updated: November 7, 2014
Last verified: November 2014
  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 Phase
Renal Cell Carcinoma
Drug: Temsirolimus
Phase 4

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 ] [ Designated as safety issue: No ]
  • The onset of interstitial lung disease in long-term use [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01420601     History of Changes
Other Study ID Numbers: B1771016
Study First Received: August 18, 2011
Last Updated: November 7, 2014
Health Authority: JAPAN:Pharmaceuticals and Medical Devices Agency (PMDA)

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

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

ClinicalTrials.gov processed this record on November 25, 2014