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| Sponsored by: |
GPC Biotech |
| Information provided by: | GPC Biotech |
| ClinicalTrials.gov Identifier: | NCT00069745 |
Purpose
PURPOSE:
The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC).
TARGET PATIENT POPULATION:
The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria.
WHAT IS SATRAPLATIN:
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. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial.
RATIONALE:
There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy
| Condition | Intervention | Phase |
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Prostate Cancer Hormone Refractory Prostate Cancer One Prior Cytotoxic Chemotherapy Regimen |
Drug: Satraplatin Drug: Prednisone |
Phase III |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Drug Information available for: | Prednisone JM 216 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations |
Show 212 Study Locations |
| GPC Biotech |
More Information
| Study ID Numbers: | GPC SAT3-03-01 |
| First Received: | September 30, 2003 |
| Last Updated: | September 10, 2007 |
| ClinicalTrials.gov Identifier: | NCT00069745 |
| Health Authority: | United States: Food and Drug Administration |
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