Back to resultsGefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Cancer of the Prostate
Eligibility Criteria
Inclusion Criteria: Relapsed prostate cancer after prostatectomy or radiotherapy PSA levels below 10 ng/mL Lymph node negative Metastasis negative Withdrawal of hormone therapy at least 6 months before entry into the study Written informed consent Exclusion Criteria: Metastatic disease Hormonal treatment 6 months before study entry Concomitant radiotherapy, surgery and/or chemotherapy ILD
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements)
Secondary Outcome Measures
TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)
Duration of PSA response
PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00241475
Brief Title
Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy
Official Title
An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Cancer of the Prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Primary Outcome Measure Information:
Title
PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements)
Secondary Outcome Measure Information:
Title
TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)
Title
Duration of PSA response
Title
PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsed prostate cancer after prostatectomy or radiotherapy
PSA levels below 10 ng/mL
Lymph node negative
Metastasis negative
Withdrawal of hormone therapy at least 6 months before entry into the study
Written informed consent
Exclusion Criteria:
Metastatic disease
Hormonal treatment 6 months before study entry
Concomitant radiotherapy, surgery and/or chemotherapy
ILD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Finland Medical Director, MD
Organizational Affiliation
AstraZeneca Finland
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Helsinki
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy
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