NCT00550810

Sutent Maintenance After Response to Taxotere

A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Alberta Health services · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial. Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.

Conditions

• Prostate Cancer
• Hormone Refractory

Interventions

Type	Name	Description
DRUG	Sunitinib (SU011248)	SU011248 (study medication) will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2 week rest period to form a complete cycle of 6 weeks. Study medication will be orally self administered once daily without regard to meals beginning on Day 1 of the study. Cycles will be repeated in the absence of unacceptable toxicity or disease progression

Timeline

• Start date: 2007-10-01
• Completion: 2012-11-01
• First posted: 2007-10-30
• Last updated: 2011-12-07

Locations

4 sites across 1 country: Canada