A Phase 1/2 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase 1/2 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
Jan 2011
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
4783-12
NCT ID:
NCT00808418
Start Date:
November 2008
Completion Date:
May 2010
Related Keywords:
- Prostate Cancer
- prostate
- cancer
- metastatic
- castration
- refractory
- elesclomol
- sodium
- docetaxel
- prednisone
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
| Pacific Coast Hematology/Oncology Medical Group | Fountain Valley, California 92708 |
| Mid Dakota Clinic | Bismarck, North Dakota 58501 |
| Mayo Clinic | Rochester, Maryland 55905 |
| University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development | San Antonio, Texas 78229 |
