Prostate Cancer Clinical Trial

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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

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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.

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Full 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.

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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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

34

Study ID:

NCT00808418

Recruitment Status:

Completed

Sponsor:

Synta Pharmaceuticals Corp.

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There are 5 Locations for this study

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Pacific Coast Hematology/Oncology Medical Group
Fountain Valley California, 92708, United States
Mayo Clinic
Rochester Maryland, 55905, United States
Mid Dakota Clinic
Bismarck North Dakota, 58501, United States
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
San Antonio Texas, 78229, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
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Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

34

Study ID:

NCT00808418

Recruitment Status:

Completed

Sponsor:


Synta Pharmaceuticals Corp.

How clear is this clinincal trial information?

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