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

Prostate Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241475
• Other study ID #: 1839IL/0155
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2005
• Last updated: April 22, 2009
• Start date: December 2003
• Est. completion date: October 2005

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Gefitinib

Locations

Country	Name	City	State
Finland	Research Site	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)
Secondary	Duration of PSA response
Secondary	PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)