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

NCT01210482 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1050

Last updated 2024-09-25

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
15 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-24
Primary Completion
2018-03-30
Completion
2018-05-31

Countries

  • Japan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01210482 on ClinicalTrials.gov