NCT00093457

Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.

Detailed description

OBJECTIVES: * Determine the efficacy of sorafenib, as measured by prostate-specific antigen response, in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate. Secondary * Determine the objective response rate and duration of response in patients treated with this drug. * Determine the tolerability and toxicity of this drug in these patients. * Determine time to treatment failure and overall survival in patients treated with this drug. * Explore the relationship between measures of ras/raf pathway activation (pERK) and response to treatment in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks after going off study treatment and then periodically for survival. Patients with stable or responding disease, when they go off study treatment, are followed every 3 months until relapse or progression. PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study within 12-18 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	BAY 43-9006 given orally at 400 mg BID in a 28 day cycle

Timeline

• Start date: 2004-08-10
• Primary completion: 2006-09-28
• Completion: 2011-01-18
• First posted: 2004-10-08
• Last updated: 2023-08-04

Locations

7 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study