A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synta Pharmaceuticals Corp.
• Treatments: Docetaxel; Prednisone

Criteria

Inclusion Criteria

• Confirmed metastatic prostate cancer

• No more than one prior chemotherapy on which the disease progressed

• ECOG performance status of less than or equal to 2

• Adequate bone marrow, renal and hepatic functions as defined in the protocol

• Neuropathy less than or equal to 2

• Reliable venous access for frequent study drug infusions

Exclusion Criteria

• Significant cardiovascular disease

• Known active brain metastases

• Subjects that have received treatment for other malignancies with in the past 5 years

• Other clinically significant uncontrolled conditions