NCT00239291

Brief Summary

To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2003

Typical duration for phase_1

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

January 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

First QC Date

October 13, 2005

Last Update Submit

April 22, 2009

Conditions

Non-Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Part A: Safety (incidence of DLTs)

  • Part B: Tolerability

Secondary Outcomes (1)

  • EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis

Interventions

Gefitinib, radiotherapyDRUG

Eligibility Criteria

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

You may qualify if:

  • Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer
  • PSA below 20 ng/mL
  • Lymph node negative
  • Non-metastatic
  • Written informed consent

You may not qualify if:

  • Well differentiated stage T2 prostate cancer (Gleason score 2 to 4)
  • Distant or nodal metastases
  • Prostatectomy
  • Concomitant LHRH analog treatment
  • Previous or concomitant anti-androgens
  • Active ILD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research site

Helsinki, Finland

Location

MeSH Terms

Interventions

GefitinibRadiotherapy

Intervention Hierarchy (Ancestors)

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

Study Officials

  • AstraZeneca Finland Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

January 1, 2003

Study Completion

May 1, 2006

Last Updated

April 23, 2009

Record last verified: 2009-04

Locations

FI(1)