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A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.
OBJECTIVES: * Determine the efficacy of sorafenib, as measured by prostate-specific antigen response, in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate. Secondary * Determine the objective response rate and duration of response in patients treated with this drug. * Determine the tolerability and toxicity of this drug in these patients. * Determine time to treatment failure and overall survival in patients treated with this drug. * Explore the relationship between measures of ras/raf pathway activation (pERK) and response to treatment in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks after going off study treatment and then periodically for survival. Patients with stable or responding disease, when they go off study treatment, are followed every 3 months until relapse or progression. PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study within 12-18 months.
Age
18 - 120 years
Sex
MALE
Healthy Volunteers
No
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Start Date
August 10, 2004
Primary Completion Date
September 28, 2006
Completion Date
January 18, 2011
Last Updated
August 4, 2023
28
ACTUAL participants
sorafenib tosylate
DRUG
Lead Sponsor
NCIC Clinical Trials Group
Collaborators
NCT06842498
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04550494