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

Agennix

Status and phase: Terminated; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Oral Satraplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00450970

SAT3-06-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 344 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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344 participants in 2 patient groups

1

Experimental group

Description:

Prednisone and Satraplatin (INN / USAN), also known as JM-216, or OC-6-43-bis(acetato-O)ammine dichloro (cyclohexanamine)-platinum (IV), is a member of a novel class of platinum (IV) compounds that are absorbed by the oral route. The lipophilic properties of these compounds, and hence their absorption, are largely determined by the nature of the axial acetate ligands.

Treatment:

Drug: Oral Satraplatin

2

Experimental group

Description:

Prednisone (17 alpha, 21-dihydroxypregna-1, 4-diene-3, 11, 20-trione) is commercially formulated as the acetate salt (prednisone 21-acetate). It is a biologically inert glucocorticoid, which is converted to active prednisolone in the liver.

Treatment:

Drug: Oral Satraplatin