Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) - Tabular View

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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.
Information provided by GPC Biotech

This Tabular View shows the required WHO registration data elements as marked by ^†

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.

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.

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. ]

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

1000

Start Date ^†

February 2007

Completion Date

December 2007

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00450970

Organization ID

SAT3-06-04

Secondary IDs ^††

Study Sponsor ^†

GPC Biotech

Collaborators ^††

Investigators ^†

Study Director:

Philippe Pultar, MD

GPC Biotech Inc.

Information Provided By

GPC Biotech

Verification Date

November 2007

First Received Date ^†

March 20, 2007

Last Updated Date

February 4, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.