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

NCT00557037 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-04-08

No results posted yet for this study

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

Interventions

DRUG

Phenoxodiol

Oral capsule, 400 mg every 8 hours daily, for 12 weeks - assement to a maximum of 12 months

Sponsors & Collaborators

  • MEI Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Kevin Kelly, MD · Yale New Haven Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557037 on ClinicalTrials.gov