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OpenTrials
Completed

NCT Number: NCT00635856

Open Label Trial to Assess Iressa in Prostate Cancer Patients

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Gefitinib

Drug

Iressa

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Phase II, Open-Label Trial to Assess the Activity of ZD1839 (IRESSA TM) in Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50mg/dl

Important dates

Study start
2001
Study completion
2003
First posted
Mar 14, 2008
Registry last updated
Apr 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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