Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
|ClinicalTrials.gov Identifier: NCT00069745|
Recruitment Status : Completed
First Posted : October 6, 2003
Last Update Posted : August 7, 2012
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.
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer Hormone Refractory Prostate Cancer||Drug: Satraplatin Drug: Prednisone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||March 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069745
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