NCT00267748

Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment. The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Sunitinib Malate Continuous Daily Dosing	Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.
DRUG	Sunitinib Malate Schedule 4/2	Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.

Timeline

• Start date: 2005-12-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2005-12-21
• Last updated: 2011-09-05
• Results posted: 2011-09-05

Locations

156 sites across 1 country: United States