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

NCT ID: NCT00808418

Last Updated: 2014-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort

Group Type EXPERIMENTAL

Elesclomol Sodium

Intervention Type DRUG

Chemotherapy agent

Docetaxel

Intervention Type DRUG

Chemotherapy agent

Interventions

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Elesclomol Sodium

Chemotherapy agent

Intervention Type DRUG

Docetaxel

Chemotherapy agent

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pacific Coast Hematology/Oncology Medical Group

Fountain Valley, California, United States

Site Status

Mayo Clinic

Rochester, Maryland, United States

Site Status

Mid Dakota Clinic

Bismarck, North Dakota, United States

Site Status

University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development

San Antonio, Texas, United States

Site Status

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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4783-12

Identifier Type: -

Identifier Source: org_study_id

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