Prostate Cancer Clinical Trial
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)
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.
*****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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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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