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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01210482
First received: September 27, 2010
Last updated: May 27, 2016
Last verified: May 2016
  Purpose

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 Intervention
Renal Cell Carcinoma
Drug: Temsirolimus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Basis Plan For Postmarketing Surveillances, Etc. Of New Ethical Drugs For Torisel

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events not expected from Japanese Package Insert [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Investigation of the incidence status and the risk factors for interstitial lung diseases [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Response rate (Responsive cases: CR, PR, PD, SD) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 1022
Study Start Date: August 2010
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
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).

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: NCT01210482

Locations
Japan
Kyusyu University Hospital
Fukuoka-shi, Fukuoka Pref, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01210482     History of Changes
Other Study ID Numbers: 3066K5-4406  B1771015 
Study First Received: September 27, 2010
Last Updated: May 27, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
Torisel
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

ClinicalTrials.gov processed this record on September 26, 2016