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OpenTrials
Completed

NCT Number: NCT00241475

Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy

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

Completed

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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

Male

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Gefitinib

Drug

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

  1. TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)

  2. Duration of PSA response

  3. PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy

Important dates

Study start
2003
Study completion
2005
First posted
Oct 19, 2005
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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