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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00241475
First received: October 18, 2005
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  Purpose

To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure


Condition Intervention Phase
Prostate Cancer
 Drug: Gefitinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Gefitinib
U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 30
Study Start Date: December 2003
Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241475

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

No publications provided

ClinicalTrials.gov Identifier: NCT00241475     History of Changes
Other Study ID Numbers: 1839IL/0155
Study First Received: October 18, 2005
Last Updated: April 22, 2009
Health Authority: Finland: Finnish Medicines Agency

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

ClinicalTrials.gov processed this record on May 21, 2013