Conditions: Prostate Cancer
Keywords: Prostate cancer metastatic disease
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 108
Healthy volunteers: no

Brief summary:
This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic disease and who have had prior anti-androgen therapy. The study will further explore the efficacy of E7389 by enrollment of patients into two strata: those who have had no prior systemic chemotherapy for their disease (except for mitoxantrone and estramustine), and those who failed no more than one previous chemotherapeutic regimen with tubulin-binding agents such as docetaxel.

Detailed description:

Arms:
arm 1: With stratification

Interventions: intervention 1: E7389
Intervention descriptions: intervention 1: Intravenous 1.4 mg/m2 on a 3-week course.

Protocol document: