drugset / Trial / NCT00557037

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

NCT00557037 ↗

Phase 2 Completed 60 enrolled MEI Pharma, Inc.
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2007-11
Primary completion
—
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Subject idronoxil Small molecule 400 mg Oral

Indications