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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00808418

Enrollment

Registered

2008-12-15

Start date

2008-11-30

Completion date

2010-05-31

Last updated

2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate, cancer, metastatic, castration, refractory, elesclomol, sodium, docetaxel, prednisone

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

Interventions

DRUGElesclomol Sodium

Chemotherapy agent

DRUGDocetaxel

Chemotherapy agent

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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	Jan 2011
To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel	Jan 2011
To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population	Jan 2011

Secondary

Measure	Time frame
To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer	Jan 2011
Evaluate OS	Jan 2011
To characterize the pharmacokinetics of elesclomol metabolites	Jan 2011

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026