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

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID: NCT00808418
Run by: Synta Pharmaceuticals Corp.
People needed: 34
Starts: 2008-11-01
Expected to finish: 2010-05-01
Last updated by the study team: 2014-02-03

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Pacific Coast Hematology/Oncology Medical Group — Fountain Valley, California, United States
Mayo Clinic — Rochester, Maryland, United States
Mid Dakota Clinic — Bismarck, North Dakota, United States
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development — San Antonio, Texas, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.