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Open Label Trial to Assess Iressa in Prostate Cancer Patients

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.
ClinicalTrials.gov Identifier: NCT00635856
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : April 23, 2009
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : May 2001
Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources


Intervention Details:
    Drug: Gefitinib
    Iressa


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

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


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
Criteria

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

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 Posted: March 14, 2008    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Iressa
Gefitinib
Prostate Cancer
PSA

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