Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over Pharmaceutical / Industry SAT3-06-04 NCT00450970

Trial Description

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.

Further Study Information

*****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.

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

GPC Biotech, Incorporated - Waltham

Philippe Pultar, MD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00450970
Information obtained from ClinicalTrials.gov on May 27, 2008