Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decided to discontinue study drug development.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Satraplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- 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.
- interventionNames
- Drug: Oral Satraplatin
- type
- EXPERIMENTAL
- label
- 2
- 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.
- interventionNames
- Drug: Oral Satraplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available