NCT00557037

A Phase II Trial of Phenoxodiol in Patients With Castrate and Non-Castrate Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: MEI Pharma, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Two groups of patients with prostate cancer will be enrolled: Group A: patients whose cancer has worsened or spread after being on hormonal therapy and has not had any chemotherapy. Group B: patients who have a rising PSA after surgery or radiotherapy for the prostate and do not have any spread to the bones or other organs. Patients will receive Phenoxodiol (PXD) 400 mg every 8 hours daily for 28 consecutive days (1 cycle). Treatment outcome will be evaluated after three cycles (12 weeks) of PXD treatment (immediately prior to cycle 4). Patients with progression of disease will be taken off study. Responding and stable disease patients will remain on study for a total of 12 cycles(approximately 12 months).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Phenoxodiol	Oral capsule, 400 mg every 8 hours daily, for 12 weeks - assement to a maximum of 12 months

Timeline

• Start date: 2007-11-01
• Completion: 2009-11-01
• First posted: 2007-11-12
• Last updated: 2010-04-08

Locations

2 sites across 1 country: United States