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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Elesclomol Sodium; Drug: Docetaxel

• Registration Number: NCT00808418
• Lead Sponsor: Synta Pharmaceuticals Corp.

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	Elesclomol Sodium	-
Cohort	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
To characterize the safety and tolerability of escalating doses of elesclomol sodium in combination with a fixed dose of docetaxel and concomitant prednisone administered weekly to m-CRPC subjects	Jan 2011
To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel	Jan 2011
To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population	Jan 2011

Secondary Outcome Measures

Name	Time	Method
To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer	Jan 2011
Evaluate OS	Jan 2011
To characterize the pharmacokinetics of elesclomol metabolites	Jan 2011

Trial Locations

Locations (5)

Mayo Clinic; 🇺🇸 Rochester, Maryland, United States

Pacific Coast Hematology/Oncology Medical Group; 🇺🇸 Fountain Valley, California, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, 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