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Open Label Trial to Assess Iressa in Prostate Cancer Patients

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 7, 2008
Last updated: April 22, 2009
Last verified: April 2009
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Alison Armour Medical Science Director, AstraZeneca Identifier: NCT00635856     History of Changes
Obsolete Identifiers: NCT00033579
Other Study ID Numbers: 1839US/0040
Study First Received: March 7, 2008
Last Updated: April 22, 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 processed this record on August 17, 2017