NCT00241475

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

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

December 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

First QC Date

October 18, 2005

Last Update Submit

April 22, 2009

Conditions

Prostate Cancer

Keywords

Cancer of the Prostate

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • 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)

Interventions

GefitinibDRUG

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Helsinki, Finland

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 Finland Medical Director, MD

    AstraZeneca Finland

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 18, 2005

First Posted

October 19, 2005

Study Start

December 1, 2003

Study Completion

October 1, 2005

Last Updated

April 23, 2009

Record last verified: 2009-04

Locations

FI(1)