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Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) (SPERA)
This study is ongoing, but not recruiting participants.
Study NCT00450970   Information provided by GPC Biotech
First Received: March 20, 2007   Last Updated: January 8, 2009   History of Changes

March 20, 2007
January 8, 2009
February 2007
 
  • 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. ]
The primary objective is to provide access to satraplatin for patients with HRPC who have been treated with one prior cytotoxic chemotherapy regimen and to evaluate the safety of satraplatin in these patients.
Complete list of historical versions of study NCT00450970 on ClinicalTrials.gov Archive Site
 
There are no secondary outcomes.
 
Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)
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.

Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Prostate Cancer
Drug: Oral Satraplatin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
1000
December 2007
 

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00450970
 
SAT3-06-04
GPC Biotech
 
Study Director: Philippe Pultar, MD GPC Biotech Inc.
GPC Biotech
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP