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

January 31, 2014 updated by: Synta Pharmaceuticals Corp.

A Phase 1 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Pacific Coast Hematology/Oncology Medical Group
    • Maryland
      • Rochester, Maryland, United States, 55905
        • Mayo Clinic
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort
Drug: Elesclomol Sodium
Chemotherapy agent
Drug: Docetaxel
Chemotherapy agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Jan 2011
Jan 2011
To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel
Time Frame: Jan 2011
Jan 2011
To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population
Time Frame: Jan 2011
Jan 2011

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synta Pharmaceuticals Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

December 12, 2008

First Submitted That Met QC Criteria

December 12, 2008

First Posted (ESTIMATE)

December 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4783-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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