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| Descriptive Information Fields | |||||
| Brief Title † | Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) | ||||
| Official Title † | Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA) | ||||
| 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 regimens for metastatic disease and 2. to evaluate the safety of oral satraplatin in this patient population. |
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| 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 Refractory Cancer (SPARC) trial. The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The companies reported that the trial did not achieve the endpoint of overall survival (p=0.80, stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The companies are currently conducting pre-specified subset analyses. Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study | ||||
| Primary Outcome Measure † | The SPERA trial is designed to provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited prior cytotoxic chemotherapy regimens for metastatic disease. [ Time Frame: Patient evaluation by MD at baseline to determine eligibility. ] To evaluate the safety of Satraplatin in these patients. [ Time Frame: Weekly blood tests and evaluation by MD prior to each cycle and for thirty days following discontinuation of the therapy. ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Prostate Cancer | ||||
| Intervention † | Drug: Oral Satraplatin | ||||
| MEDLINE PMIDs | |||||
| Links | Click here for more information about this study: The SPERA Trial-Satraplatin Expanded Access Protocol ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 1000 | ||||
| Start Date † | February 2007 | ||||
| Completion Date | December 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00450970 | ||||
| Organization ID | SAT3-06-04 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | GPC Biotech | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | GPC Biotech | ||||
| Verification Date | November 2007 | ||||
| First Received Date † | March 20, 2007 | ||||
| Last Updated Date | February 4, 2008 | ||||