CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,050 enrolled
Drug / intervention
Temsirolimusdrug
Likely dose
Temsirolimus 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01210482
NCT01210482N/ACompleted
CompareCT.gov

SAFETY AND EFFECTIVENESS OF TEMSIROLIMUS IN JAPANESE PATIENTS WITH UNRESECTABLE OR METASTATIC RENAL CELL CARCINOMA: A POST-MARKETING, ALL-CASE SURVEILLANCE STUDY INCLUDING B1771016 STUDY - SURVEY ON LONG-TERM USE -

Pfizer·observational·Posted Sep 28, 2010·Updated Sep 25, 2024

In Brief

An observational study evaluating Temsirolimus for Renal Cell Carcinoma. Completed, enrolled 1,050 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2010
Enrollment StartAug 24, 2010
Primary CompletionMar 30, 2018
Study CompletionMay 31, 2018
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 15.8 years ago

Interventions

Temsirolimusdrug

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.