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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Principal Investigator

AstraZeneca Finland Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca Finland

Authority:

Finland: Finnish Medicines Agency

Study ID:

1839IL/0155

NCT ID:

NCT00241475

Start Date:

December 2003

Completion Date:

October 2005

Related Keywords:

  • Prostate Cancer
  • Cancer of the Prostate
  • Prostatic Neoplasms

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