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

Last updated on April 11, 2018

FOR MORE INFORMATION
Study Location
Kinki University Hospital
Osakasayama, Osaka, 589-8511 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients not administered Torisel.

- Patients with a history of severe hypersensitivity to temsirolimus, sirolimus
derivative, or any of their components and/or derivatives.

NCT01420601
Pfizer
Active, not recruiting
Temsirolimus (Torisel) Special Investigation (Regulatory Post Marketing Commitment Plan)

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Temsirolimus (Torisel) Special Investigation (Regulatory Post Marketing Commitment Plan)
Torisel 25mg For Intravenous Drip Infusion Special Investigation - Survey On Long-term Use -
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.
Implemented as a Drug Use Investigation by Central Registration System
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
Renal Cell Carcinoma
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
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.
Intervention: Drug: Temsirolimus
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
January 2018
January 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01420601
B1771016
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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