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

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Kyusyu University Hospital
Fukuoka-shi, Fukuoka PREF, 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
0-99
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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Descriptive Information
Brief TitleTemsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official TitleBasis 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 DescriptionImplemented as a Drug Use Investigation by Central Registration System
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
ConditionRenal Cell Carcinoma
InterventionDrug: 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/CohortsTemsirolimus
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 StatusCompleted
Actual Enrollment
 (submitted: September 14, 2018)
1022
Original Estimated Enrollment
 (submitted: September 27, 2010)
600
Actual Study Completion DateMarch 2018
Actual Primary Completion DateMarch 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
Agesup to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01210482
Other Study ID Numbers3066K5-4406
B1771015 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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