Trial intelligence / Profile preview

Temsirolimus vs Sorafenib in Advanced RCC (INTORSECT)

NCT00474786Phase 3

Key facts

Status: Completed
Start: Sep 2007
Primary completion: Jan 2012
Countries: 20
Sponsor: Pfizer
Modality: Small Molecules

Drugs: temsirolimus
Conditions: renal cell carcinoma (RCC)

Overview

Phase 3, randomised, open-label trial of temsirolimus in renal cell carcinoma (RCC) (2 arms), sponsored by Pfizer. Primary endpoint: Progression-Free Survival at 24 months. Started Sep 2007; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Sorafenib
Sorafenib 400 mg PO BID
Temsirolimus
Temsirolimus 25 mg IV Weekly

Who it enrols

Patients with metastatic RCC who have progressed on first-line sunitinib. Excludes patients with CNS metastases or those who discontinued sunitinib due to intolerance.

Endpoints

Primary

Progression-Free Survival24 months

Secondary

Progression-Free Survival by Investigator Assessment24 months
Percentage of Participants With Tumor Response24 months
Overall Survival24 months
Duration of Response24 months

Results

Not all primary endpoints met

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