Status:
COMPLETED
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
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 docet...
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 docet...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00808418
Start Date
November 1 2008
End Date
May 1 2010
Last Update
February 3 2014
Active Locations (5)
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1
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, United States, 92708
2
Mayo Clinic
Rochester, Maryland, United States, 55905
3
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
4
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229