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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00808418
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : February 3, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Elesclomol Sodium Drug: Docetaxel Phase 1

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  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)
Study Start Date : November 2008
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cohort Drug: Elesclomol Sodium
Chemotherapy agent
Drug: Docetaxel
Chemotherapy agent



Primary Outcome Measures :
  1. 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 ]
  2. To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel [ Time Frame: Jan 2011 ]
  3. To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population [ Time Frame: Jan 2011 ]

Secondary Outcome Measures :
  1. To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer [ Time Frame: Jan 2011 ]
  2. Evaluate OS [ Time Frame: Jan 2011 ]
  3. To characterize the pharmacokinetics of elesclomol metabolites [ Time Frame: Jan 2011 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808418


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

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00808418     History of Changes
Other Study ID Numbers: 4783-12
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014

Keywords provided by Synta Pharmaceuticals Corp.:
prostate
cancer
metastatic
castration
refractory
elesclomol
sodium
docetaxel
prednisone

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisone
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal