CClinicalTrials.gg
CompletedNCT00635856Updated Apr 23, 2009

Open Label Trial to Assess Iressa in Prostate Cancer Patients

A Phase 2 interventional study of Gefitinib in Prostate Cancer, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-23.

Sponsored by AstraZeneca · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and who have rising PSA levels

02

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • Iressa
  • Gefitinib
  • Prostate Cancer
  • PSA
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Prostate cancer diagnosis
  • no evidence of metastasis
  • Age 18 or older

Exclusion criteria

Exclusion Criteria:

  • Prior chemotherapy for recurrent prostate cancer
  • Radiotherapy completed within 28 days of starting the study
  • Incomplete healing from prior cancer or other major surgery
05

Study design

Phase
Phase 2
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Interventions

  • DrugGefitinib

    Iressa

06

What researchers measure

Primary outcomes

  1. Serum Prostate Specific Antigen

    Time frame: Monthly

Secondary outcomes

  1. Duration of PSA decline

    Time frame: Monthly

  2. Safety variables

    Time frame: Monthly

  3. Time to Progression

    Time frame: Every 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00635856
Lead sponsor
AstraZeneca
First posted
Mar 14, 2008
Start date
May 2001
Completion
Feb 2003
Last update
Apr 23, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion