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Trial record 1 of 1 for:    NCT01210482
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Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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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

Tracking Information
First Submitted Date September 27, 2010
First Posted Date September 28, 2010
Last Update Posted Date September 17, 2018
Actual Study Start Date August 2010
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 27, 2010)
  • The incidence of adverse events [ Time Frame: 24 weeks ]
  • Adverse events not expected from Japanese Package Insert [ Time Frame: 24 weeks ]
  • Investigation of the incidence status and the risk factors for interstitial lung diseases [ Time Frame: 24 weeks ]
  • Response rate (Responsive cases: CR, PR, PD, SD) [ Time Frame: 24 weeks ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01210482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 27, 2010)
Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items) [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official Title Basis Plan For Postmarketing Survelillances, Etc. Of New Ethical Drugs For Torisel
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.
Detailed Description Implemented as a Drug Use Investigation by Central Registration System
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
Condition Renal Cell Carcinoma
Intervention 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
Study Groups/Cohorts Temsirolimus
Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma)
Intervention: Drug: Temsirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 14, 2018)
1022
Original Estimated Enrollment
 (submitted: September 27, 2010)
600
Actual Study Completion Date March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01210482
Other Study ID Numbers 3066K5-4406
B1771015 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2018