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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00450970 |
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Date of registration:
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20/03/2007 |
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Primary sponsor: |
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Public title:
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Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)
SPERA |
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Scientific title:
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Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA) |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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344 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00450970 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Philippe Pultar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GPC Biotech Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: Oral Satraplatin
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Primary Outcome(s)
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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.]
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Secondary ID(s)
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SAT3-06-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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