Open Label Trial to Assess Iressa in Prostate Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00635856
First received: March 7, 2008
Last updated: April 22, 2009
Last verified: April 2009
  Purpose

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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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
    Iressa
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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

No publications provided

Responsible Party: Alison Armour Medical Science Director, AstraZeneca
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014