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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00241475

1839IL/0155

Details and patient eligibility

About

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

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)