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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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Elesclomol Sodium
Docetaxel
Sponsored by
Synta Pharmaceuticals Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate, cancer, metastatic, castration, refractory, elesclomol, sodium, docetaxel, prednisone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pacific Coast Hematology/Oncology Medical Group
  • Mayo Clinic
  • Mid Dakota Clinic
  • University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort

Arm Description

Outcomes

Primary Outcome Measures

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
To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel
To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population

Secondary Outcome Measures

To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer
Evaluate OS
To characterize the pharmacokinetics of elesclomol metabolites

Full Information

First Posted
December 12, 2008
Last Updated
January 31, 2014
Sponsor
Synta Pharmaceuticals Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT00808418
Brief Title
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
A Phase 1 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synta Pharmaceuticals Corp.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate, cancer, metastatic, castration, refractory, elesclomol, sodium, docetaxel, prednisone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Elesclomol Sodium
Intervention Description
Chemotherapy agent
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Chemotherapy agent
Primary Outcome Measure Information:
Title
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
Title
To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel
Time Frame
Jan 2011
Title
To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population
Time Frame
Jan 2011
Secondary Outcome Measure Information:
Title
To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer
Time Frame
Jan 2011
Title
Evaluate OS
Time Frame
Jan 2011
Title
To characterize the pharmacokinetics of elesclomol metabolites
Time Frame
Jan 2011

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Pacific Coast Hematology/Oncology Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Maryland
ZIP/Postal Code
55905
Country
United States
Facility Name
Mid Dakota Clinic
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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