NCT00964002

Efavirenz in Treating Patients With Metastatic Prostate Cancer

A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with metastatic prostate cancer.

Detailed description

OBJECTIVES: Primary * To assess the effect of efavirenz on the PSA non-progression rate at 3 months in patients with castration-refractory metastatic prostate cancer. Secondary * To assess the effect of efavirenz on the PSA non-progression rate at 6 months. * To assess the effect of efavirenz on overall survival. * To assess the effect of efavirenz on PSA progression-free survival.. * To assess the tolerability and safety profile of efavirenz. OUTLINE: This is a multicenter study. Patients receive oral efavirenz once daily in the absence of disease progression or unacceptable toxicity.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	efavirenz

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-09-19
• Completion: 2014-04-08
• First posted: 2009-08-24
• Last updated: 2022-05-16
• Results posted: 2022-05-16

Locations

1 site across 1 country: France