Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00069745
First received: September 30, 2003
Last updated: August 1, 2012
Last verified: August 2012

September 30, 2003
August 1, 2012
September 2003
January 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00069745 on ClinicalTrials.gov Archive Site
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Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
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

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

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Prostate Cancer
  • Hormone Refractory Prostate Cancer
  • Drug: Satraplatin
  • Drug: Prednisone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2007
January 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stage D2 metastatic prostate cancer
  • Progression after one prior chemotherapy
  • ECOG Performance status equal / less than 2
  • Life expectancy > 3 months
  • Surgical or medical castration
  • Adequate bone marrow, hepatic and renal functions
  • Informed consent

Exclusion Criteria:

  • More than one prior chemotherapy
  • Prior platinum containing compounds
  • Prior malignancy
  • Prior significant RT/radionuclide therapy
  • Major GI surgery or GI disease affecting absorption
  • Disease with contraindication to steroids
  • Brain metastases
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Croatia,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Peru,   Poland,   Russian Federation,   Spain,   United Kingdom
 
NCT00069745
GPC SAT3-03-01
Not Provided
Agennix
Agennix
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Agennix
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP