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

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ClinicalTrials.gov Identifier: NCT01420601
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Renal Cell Carcinoma Drug: Temsirolimus

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

Study Design
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Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Torisel 25mg For Intravenous Drip Infusion Special Investigation - Survey On Long-term Use -
Actual Study Start Date : September 2011
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   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).
  • 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
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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
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Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01420601     History of Changes
Other Study ID Numbers: B1771016
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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

Additional relevant 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
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents