NCT00265070

Brief Summary

This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

First QC Date

December 12, 2005

Last Update Submit

February 4, 2013

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate

Secondary Outcomes (4)

  • To estimate the duration of PSA response

  • To estimate the partial PSA response rate

  • To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline

  • To investigate the change in PSA levels after discontinuation of ZD1839

Interventions

GefitinibDRUG

250 mg tablet oral daily dose

Also known as: Iressa®, ZD1839

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Removal of prostate for prostate cancer
  • Raised level of prostate specific antigen (PSA) post-surgery
  • Can have received some radiation therapy

You may not qualify if:

  • Any after surgery male hormone blocking therapy.
  • Low white blood cell count
  • Abnormal liver function test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Vancouver, British Columbia, Canada

Location

Research Site

London, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Montreal, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • AstraZeneca Canada Oncology Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 14, 2005

Study Start

January 1, 2003

Study Completion

August 1, 2011

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

CA(4)