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

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NCT01210482

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Kyusyu University Hospital
Fukuoka-shi, Fukuoka PREF, Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
0-99
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).

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.

NCT01210482
Pfizer
Completed
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Basis Plan For Postmarketing Survelillances, Etc. Of New Ethical Drugs For Torisel

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.
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 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
Temsirolimus
Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma)
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
600
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).

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
up to 99 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01210482
3066K5-4406
B1771015 ( Other Identifier: Alias Study Number )
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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