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 - Tabular View

Tracking Information
First Received Date ^ICMJE	December 12, 2008
Last Updated Date	March 6, 2009
Start Date ^ICMJE	November 2008
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 12, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00808418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 12, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	A Phase 1/2 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)
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.
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 Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Drug: Elesclomol Sodium Drug: Docetaxel
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Estimated Enrollment ^ICMJE	34
Estimated Completion Date	May 2010
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00808418
Responsible Party	David Hynds, Clinical Trials Manager, Synta Pharmaceuticals
Study ID Numbers ^ICMJE	4783-12
Study Sponsor ^ICMJE	Synta Pharmaceuticals, Corp.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Synta Pharmaceuticals, Corp.
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP