CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 512 enrolled
Drug / intervention
Sorafenib +1 moredrug
Likely dose
Sorafenib 400 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/NCT00474786
NCT00474786Phase 3Completed
CompareCT.gov

A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy

Pfizer·interventional·Posted May 17, 2007·Updated Nov 21, 2013

In Brief

A Phase 3 clinical trial evaluating Sorafenib and temsirolimus (Torisel) for Renal Cell Carcinoma. Completed, enrolled 512 participants across 128 sites in 20 countries.

Detailed Summary

This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesArgentina, Australia, Austria, Canada, Chile, China, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Singapore, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 17, 2007
Enrollment StartSep 1, 2007
Primary CompletionJan 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.1 years ago

Interventions

Sorafenibdrug

Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).

temsirolimus (Torisel)drug

Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.