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Open Label Trial to Assess Iressa in Prostate Cancer Patients

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 14, 2008
Last Update Posted: April 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and who have rising PSA levels

Condition Intervention Phase
Prostate Cancer Drug: Gefitinib Phase 2

AstraZeneca has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase II, Open-Label Trial to Assess the Activity of ZD1839 (IRESSA TM) in Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50mg/dl

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Serum Prostate Specific Antigen [ Time Frame: Monthly ]

Secondary Outcome Measures:
  • Duration of PSA decline [ Time Frame: Monthly ]
  • Safety variables [ Time Frame: Monthly ]
  • Time to Progression [ Time Frame: Every 3 months ]

Estimated Enrollment: 100
Study Start Date: May 2001
Study Completion Date: February 2003
Intervention Details:
    Drug: Gefitinib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Alison Armour Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00635856     History of Changes
Obsolete Identifiers: NCT00033579
Other Study ID Numbers: 1839US/0040
First Submitted: March 7, 2008
First Posted: March 14, 2008
Last Update Posted: April 23, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action