- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00265070
Trial of Iressa in Prostate Cancer Patients
February 4, 2013 updated by: AstraZeneca
An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy
This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.
Study Overview
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montreal, Canada
- Research Site
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British Columbia
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Vancouver, British Columbia, Canada
- Research Site
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Ontario
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London, Ontario, Canada
- Research Site
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Toronto, Ontario, Canada
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Removal of prostate for prostate cancer
- Raised level of prostate specific antigen (PSA) post-surgery
- Can have received some radiation therapy
Exclusion Criteria:
- Any after surgery male hormone blocking therapy.
- Low white blood cell count
- Abnormal liver function test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate
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Secondary Outcome Measures
Outcome Measure |
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To estimate the duration of PSA response
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To estimate the partial PSA response rate
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To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline
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To investigate the change in PSA levels after discontinuation of ZD1839
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: AstraZeneca Canada Oncology Medical Director, MD, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
December 12, 2005
First Submitted That Met QC Criteria
December 12, 2005
First Posted (Estimate)
December 14, 2005
Study Record Updates
Last Update Posted (Estimate)
February 5, 2013
Last Update Submitted That Met QC Criteria
February 4, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1839IL/0093
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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