NCT00635856

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started May 2001

Shorter than P25 for phase_2 prostate-cancer

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

May 1, 2001

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

First QC Date

March 7, 2008

Last Update Submit

April 22, 2009

Conditions

Prostate Cancer

Keywords

IressaGefitinibProstate CancerPSA

Outcome Measures

Primary Outcomes (1)

  • Serum Prostate Specific Antigen

    Monthly

Secondary Outcomes (3)

  • Duration of PSA decline

    Monthly

  • Safety variables

    Monthly

  • Time to Progression

    Every 3 months

Interventions

GefitinibDRUG

Iressa

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Expanded Access
Yes

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

May 1, 2001

Study Completion

February 1, 2003

Last Updated

April 23, 2009

Record last verified: 2009-04