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A Phase 1/2 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Phase 1/2 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Jan 2011

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

4783-12

NCT ID:

NCT00808418

Start Date:

November 2008

Completion Date:

May 2010

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • metastatic
  • castration
  • refractory
  • elesclomol
  • sodium
  • docetaxel
  • prednisone
  • Prostatic Neoplasms

Name

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Pacific Coast Hematology/Oncology Medical GroupFountain Valley, California  92708
Mid Dakota ClinicBismarck, North Dakota  58501
Mayo ClinicRochester, Maryland  55905
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug DevelopmentSan Antonio, Texas  78229