NCT00414388

Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer

Phase I/II Study to Evaluate the Ability of Sorafenib in Overcoming Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer (AIPC)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Oncology Specialists, S.C. · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.

Detailed description

Patients who have AIPC and are progressing despite systemic chemotherapy will be offered participation in this study. Patients who relapse or progress shortly (within 12 weeks) after discontinuation of chemotherapy with either docetaxel/prednisone or mitoxantrone/prednisone will also be offered participation in this trial. Enrolled patients will receive sorafenib as per protocol define dose. Sorafenib will be administered in combination with the last chemotherapy utilized. If there is no disease progression after 6 cycles, chemotherapy will be stopped and Sorafenib may continue until disease progression.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib	400mg twice daily

Timeline

• Start date: 2006-12-01
• Primary completion: 2011-09-01
• Completion: 2012-03-01
• First posted: 2006-12-21
• Last updated: 2014-04-07
• Results posted: 2014-04-07

Locations

2 sites across 1 country: United States