Status:
TERMINATED
Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)
Lead Sponsor:
Agennix
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The SPERA trial is designed to 1. provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited cytotoxic chemotherapy reg...
Detailed Description
\*\*\*\*\*UPDATE\*\*\*\*\* On October 30th, 2007 GPC Biotech announced topline overall survival results for the Phase III trial in hormone refractory prostate cancer-Satraplatin and Prednisone Against...
Eligibility Criteria
Inclusion
- Metastatic(Stage D2)prostate cancer
- Progression after unlimited prior cytotoxic chemotherapy regimens
- ECOG Performance status equal/less than 2
- Surgical or medical castration
- Adequate bone marrow, liver, and renal function
- Informed consent
- Patients treated with bisphosphonates prior to entry are eligible and should continue bisphosphonates therapy while on this trial
Exclusion
- Serious concurrent uncontrolled medical disorder
- Malignant disease requiring on-going therapy
- Prior significant RT/radionuclide therapy
- Major GI surgery or GI disease affecting absorption
- Disease where corticosteroids are contraindicated
- Brain metastases
- Poorly-controlled or uncontrolled insulin-dependent diabetes
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00450970
Start Date
February 1 2007
End Date
December 1 2009
Last Update
August 17 2012
Active Locations (121)
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1
Carraway Cancer Clinic
Birmingham, Alabama, United States, 35234
2
Birmingham Hematology and Oncology
Birmingham, Alabama, United States, 35235
3
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
4
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508