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
  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
Prostate Cancer
Hormone Refractory Prostate Cancer
Drug: Satraplatin
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Agennix:

Study Start Date: September 2003
Study Completion Date: March 2007
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069745

  Show 211 Study Locations
Sponsors and Collaborators
Agennix
  More Information

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00069745     History of Changes
Other Study ID Numbers: GPC SAT3-03-01
Study First Received: September 30, 2003
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
Prostatic Neoplasms
Cancer Treatment Protocols
Antineoplastic protocols
One Prior Cytotoxic Chemotherapy Regimen

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Satraplatin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 01, 2014