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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00808418
First received: December 12, 2008
Last updated: January 31, 2014
Last verified: January 2014

December 12, 2008
January 31, 2014
November 2008
May 2010   (final data collection date for primary 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 [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]
  • To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00808418 on ClinicalTrials.gov Archive Site
  • To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer [ Time Frame: Jan 2011 ] [ Designated as safety issue: No ]
  • Evaluate OS [ Time Frame: Jan 2011 ] [ Designated as safety issue: No ]
  • To characterize the pharmacokinetics of elesclomol metabolites [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Elesclomol Sodium
    Chemotherapy agent
  • Drug: Docetaxel
    Chemotherapy agent
Experimental: Cohort
Interventions:
  • Drug: Elesclomol Sodium
  • Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00808418
4783-12
No
Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp.
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP