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A Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer

NCT00430235 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2010-08-05

No results posted yet for this study

Summary

Purpose:

To determine the efficacy of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve hormone-refractory prostate cancer.

Hypothesis:

That there will be PSA response when BAY 43-9006 in combination with bicalutamide is given to patients with chemo-naïve hormone-refractory prostate cancer.

Conditions

  • Adenocarcinoma of the Prostate

Interventions

DRUG

BAY 43-9006

BAY 43-9006, 400 mg, PO, BID in a 28-day cycle(morning and evening) Bicalutamide 50 mg po Once daily in a 28-day cycle (morning)

Sponsors & Collaborators

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Kim N Chi, MD · British Columbia Cancer Agency

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-08-31

Countries

  • Canada

Study Locations

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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 NCT00430235 on ClinicalTrials.gov