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Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy

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: NCT00241475
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : April 23, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Gefitinib Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy
Study Start Date : December 2003
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements)

Secondary Outcome Measures :
  1. TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)
  2. Duration of PSA response
  3. PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)

Eligibility Criteria

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:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed prostate cancer after prostatectomy or radiotherapy
  • PSA levels below 10 ng/mL
  • Lymph node negative
  • Metastasis negative
  • Withdrawal of hormone therapy at least 6 months before entry into the study
  • Written informed consent

Exclusion Criteria:

  • Metastatic disease
  • Hormonal treatment 6 months before study entry
  • Concomitant radiotherapy, surgery and/or chemotherapy
  • ILD
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241475


Locations
Finland
Research Site
Helsinki, Finland
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Finland Medical Director, MD AstraZeneca Finland
More Information

ClinicalTrials.gov Identifier: NCT00241475     History of Changes
Other Study ID Numbers: 1839IL/0155
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Cancer of the Prostate

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