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

Synta Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: Docetaxel

Drug: Elesclomol Sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00808418

4783-12

Details and patient eligibility

About

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.

Full description

Enrollment

34 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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