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

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agennix
• Treatments: Hormones; Prednisone; Satraplatin

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