Status:

COMPLETED

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

Lead Sponsor:

Synta Pharmaceuticals Corp.

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

PHASE1

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 docet...

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 docet...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2010

    Estimated Enrollment :

    34 Patients enrolled

    Trial Details

    Trial ID

    NCT00808418

    Start Date

    November 1 2008

    End Date

    May 1 2010

    Last Update

    February 3 2014

    Active Locations (5)

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    Page 1 of 2 (5 locations)

    1

    Pacific Coast Hematology/Oncology Medical Group

    Fountain Valley, California, United States, 92708

    2

    Mayo Clinic

    Rochester, Maryland, United States, 55905

    3

    Mid Dakota Clinic

    Bismarck, North Dakota, United States, 58501

    4

    University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development

    San Antonio, Texas, United States, 78229