drugset / Trial / NCT00082134

Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel

NCT00082134 ↗

Phase 2 Completed 40 enrolled Genzyme, a Sanofi Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this study that is expected to last 24 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The primary objective of this study is to determine the PSA response rate. The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651.

Timeline

Start
—
Primary completion
—
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject TASIDOTIN Protein / enzyme biologic — Intravenous