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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
AstraZeneca Finland Medical Director, MD
Study Director
AstraZeneca Finland
Finland: Finnish Medicines Agency
1839IL/0155
NCT00241475
December 2003
October 2005
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