Open Label Trial to Assess Iressa in Prostate Cancer Patients

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00635856
• Lead Sponsor: AstraZeneca

Brief Summary

A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and who have rising PSA levels

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study Completion: 2003-02
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-22
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Prostate cancer diagnosis
• no evidence of metastasis
• Age 18 or older

Exclusion Criteria

• Prior chemotherapy for recurrent prostate cancer
• Radiotherapy completed within 28 days of starting the study
• Incomplete healing from prior cancer or other major surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Serum Prostate Specific Antigen	Monthly

Secondary Outcome Measures

Name	Time	Method
Duration of PSA decline	Monthly
Safety variables	Monthly
Time to Progression	Every 3 months