Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) (SPERA)

August 9, 2012 updated by: Agennix

Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA)

The SPERA trial is designed to 1. provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited cytotoxic chemotherapy regimens for metastatic disease and 2. to evaluate the safety of oral satraplatin in this patient population.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

*****UPDATE***** On October 30th, 2007 GPC Biotech announced topline overall survival results for the Phase III trial in hormone refractory prostate cancer-Satraplatin and Prednisone Against Refractory Cancer (SPARC) trial.

The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The companies reported that the trial did not achieve the endpoint of overall survival (p=0.80, stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The companies are currently conducting pre-specified subset analyses.

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.

Study Type

Interventional

Enrollment (Actual)

344

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35234
        • Carraway Cancer Clinic
      • Birmingham, Alabama, United States, 35235
        • Birmingham Hematology and Oncology
      • Homewood, Alabama, United States, 35209
        • Urology Centers Of Alabama
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
      • Jonesboro, Arkansas, United States, 72401
        • Clopton Clinic
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc
      • Burbank, California, United States, 91505
        • East Valley Hematology Oncology Medical Group
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Mission Hills, California, United States, 91345
        • North Valley Hematology/Oncology Medical Group
      • Mission Viejo, California, United States, 92691
        • Michael Harris MD
      • Newport Beach, California, United States, 92663
        • Newport Cancer Care Medical Assoc., Inc.
      • Orange, California, United States, 92868
        • Medical Oncology Care Associates
      • Rancho Mirage, California, United States, 92270
        • Desert Cancer Center
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
      • San Francisco, California, United States, 94115
        • Pacific Hematology Oncology Associates
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Hematology Oncology Medical Group
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Hemotology
      • Stockton, California, United States, 95204
        • Stockton Hematology Oncology Medical Group
      • Truckee, California, United States, 96161
        • Sierra Nevada Oncology
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Rocky Mountain Cancer Center
    • Connecticut
      • Bridgeport, Connecticut, United States, 06611
        • Oncology Associates of Bridgeport
      • Fairfield, Connecticut, United States, 06284
        • Medical Specialists of Fairfield, LLC
      • Manchester, Connecticut, United States, 06040
        • Davis, Posteraro, and Wasser, MDs, LLP
      • Norwalk, Connecticut, United States, 06856
        • Whittigham Cancer Center at Norwalk Hospital
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology Associates
      • Stamford, Connecticut, United States, 06902
        • Hematology Oncology
      • Torrington, Connecticut, United States, 06790
        • Connecticut Oncology & Hematology, LLP
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Center for Hematology-Oncology
      • Bradenton, Florida, United States, 34209
        • Florida Cancer Specalists
      • Fort Myers, Florida, United States, 33908
        • Florida Cancer Care Specialists-Fort Myers Summerlin Office
      • Gainesville, Florida, United States, 32605
        • Gainesville Hematology Oncology Associates
      • Jacksonville, Florida, United States, 32256
        • ICON
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Medical Center
      • Melbourne, Florida, United States, 32901
        • MIMA Century Research Assoc.
      • Miami, Florida, United States, 33138
        • Marc I. Saltzman
      • Ocala, Florida, United States, 34474
        • Ocala Oncology Center
      • Orange City, Florida, United States, 32763
        • Mid-Florida Hematology & Oncology Centers
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Hospital Cancer Research
      • Port Charlotte, Florida, United States, 33980
        • Florida Cancer Specialists
    • Georgia
      • Athens, Georgia, United States, 30607
        • Notheast Georgia Cancer Care, LLC
      • Augusta, Georgia, United States, 30901
        • Medical Oncology Assoc. of Augusta, PC
      • Decatur, Georgia, United States, 30033
        • GA Urology
      • Lawrenceville, Georgia, United States, 30045
        • Suburban Hematology-Oncology Assoc., PC
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Galesburg, Illinois, United States, 61401
        • Medical & Surgical Spealists, LLC
      • Mattoon, Illinois, United States, 61938
        • Urology Associates, S.C.
      • Normal, Illinois, United States, 61761
        • Mid-Illinois Hematology and Oncology Assoc., LTD
      • Peoria, Illinois, United States, 61615
        • Oncology Hematology Associates of Central IL, PC
    • Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Fort Wayne Medical Oncology Hematology, Inc.
      • Hammond, Indiana, United States, 46320
        • Mahendra M. Shah, MD, FACP
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC
      • Cedar Rapids, Iowa, United States, 52402
        • Iowa Blood and Cancer Care, PLC
      • Council Bluffs, Iowa, United States, 51503
        • Heartland Oncology & Hematology, LLP
      • Waterloo, Iowa, United States, 50702
        • Cedar Valley Medical Specialists
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Drs.Caroll, Sheth and Raghavan
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
      • Hagerstown, Maryland, United States, 21740
        • The Center for Clinical Research
      • Rockville, Maryland, United States, 20850
        • Associates in Oncology/Hematology
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Cancer & Hematology Centers of Western Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Kalamazoo Hematology and Oncology
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates
      • Tupelo, Mississippi, United States, 38801
        • NW MS Hem/Onc (Tupelo)
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center
      • Columbia, Missouri, United States, 65201
        • Columbia Comprehensive Cancer Care Center
      • St. Louis, Missouri, United States, 63141
        • St. Johns Mercy Medical Center
      • St. Louis, Missouri, United States, 63141
        • The Center for Cancer Care & Research
    • Montana
      • Billings, Montana, United States, 59101
        • The Billings Clinic
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Saint Francis Memoiral Hospital
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Hematology-Oncology,PC
    • New Jersey
      • Denville, New Jersey, United States, 07834
        • Cancer Care at St. Claire's
      • Morristown, New Jersey, United States, 07960
        • Hematology Oncology Associates of Northern New Jersey
      • Westwood, New Jersey, United States, 07675
        • Northern Valley Medical
    • New York
      • Bay Shore, New York, United States, 11706
        • Hematology Oncology Assoc. of W. Suffolk, PC
      • Cooperstown, New York, United States, 13326
        • The Mary Imogene Bassett Hospital
      • E. Setauket, New York, United States, 11733
        • North Shore Hematology Oncology Assoc.
      • Staten Island, New York, United States, 10310
        • Richmond University Medical Center
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Gaston Hematology and Oncology
      • Raleigh, North Carolina, United States, 27614
        • Cancer Center of North Carolina
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • MeritCare Clinical Research
      • Minot, North Dakota, United States, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Tricounty Hem/Onc Associates
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Columbus, Ohio, United States, 43219
        • Mid-Ohio Oncology/Hematology
      • Columbus, Ohio, United States, 43235
        • Hematology-Oncology Consultants, Inc
      • Mansfield, Ohio, United States, 44907
        • Ohio Cancer Specialists
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Cancer Care Associates
      • Oklahoma City, Oklahoma, United States, 73112
        • Cancer Specialists Of Oklahoma
      • Tulsa, Oklahoma, United States, 73146
        • Cancer Care Associates
    • Pennsylvania
      • Ephrata, Pennsylvania, United States, 17522
        • Ephrata Cancer Center
      • Lancaster, Pennsylvania, United States, 17601
        • Lancaster Cancer Center, Ltd.
      • Philadelphia, Pennsylvania, United States, 19114
        • Greater Philadelphia Cancer Center
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Carolina Health Care
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic
      • Germantown, Tennessee, United States, 38138
        • Mid-South Cancer Center
      • Germantown, Tennessee, United States, 38138
        • Mid-South Cancer Center, PC
      • Johnson City, Tennessee, United States, 37604
        • McLeod Cancer and Blood Center
      • Kingsport, Tennessee, United States, 37660
        • Kingsport Hematology Oncology
      • Memphis, Tennessee, United States, 38104
        • Boston Baskin Cancer Group D/B/A/ UTCI
    • Texas
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
      • Austin, Texas, United States, 78759
        • Lone Star Oncology Consultants
      • Austin, Texas, United States, 78731
        • Texas Oncology Cancer Center, PA
      • Corpus Christi, Texas, United States, 78463
        • Coastal Bend Cancer Center
      • Daingerfield, Texas, United States, 75638
        • Mitchell Medical Clinic
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research and Treatment
      • Dallas, Texas, United States, 75231
        • Texas Oncology
      • Dallas, Texas, United States, 75235
        • Clinical Oncology & Hematology, LLP
      • Dallas, Texas, United States, 75237
        • Dallas Oncology Consultants, PA
      • Denton, Texas, United States, 76210
        • Texas Cancer Center
      • Fredericksburg, Texas, United States, 78624
        • Cancer Care Centers of South Texas
      • Midland, Texas, United States, 79701
        • Allison Cancer Center
      • New Braunfels, Texas, United States, 78130
        • Cancer Care Centers of South Texas
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates
      • Newport News, Virginia, United States, 23601
        • Peninsula Cancer Institute
    • Washington
      • Spokane, Washington, United States, 99204
        • Sacred Heart Medical Center - Providence Cancer Care Center
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, PC
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Green Bay Oncology, Ltd.
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Prednisone and Satraplatin (INN / USAN), also known as JM-216, or OC-6-43-bis(acetato-O)ammine dichloro (cyclohexanamine)-platinum (IV), is a member of a novel class of platinum (IV) compounds that are absorbed by the oral route. The lipophilic properties of these compounds, and hence their absorption, are largely determined by the nature of the axial acetate ligands.
Drug: Oral Satraplatin
The SPERA protocol states that satraplatin may be continued until evidence of disease progression (at the discretion of the investigator), intolerable toxicity, withdrawal of informed consent, or non compliance. The treatment consists of satraplatin 80 mg/m2 administered by mouth once daily for five consecutive days (days 1-5) plus prednison 5 mg po twice daily. The treatment cycle is repeated every 35 days.
Experimental: 2
Prednisone (17 alpha, 21-dihydroxypregna-1, 4-diene-3, 11, 20-trione) is commercially formulated as the acetate salt (prednisone 21-acetate). It is a biologically inert glucocorticoid, which is converted to active prednisolone in the liver.
Drug: Oral Satraplatin
The SPERA protocol states that satraplatin may be continued until evidence of disease progression (at the discretion of the investigator), intolerable toxicity, withdrawal of informed consent, or non compliance. The treatment consists of satraplatin 80 mg/m2 administered by mouth once daily for five consecutive days (days 1-5) plus prednison 5 mg po twice daily. The treatment cycle is repeated every 35 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Patient evaluation by MD at baseline to determine eligibility.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agennix

Investigators

  • Study Director: Philippe Pultar, MD, GPC Biotech Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 21, 2007

First Posted (Estimate)

March 22, 2007

Study Record Updates

Last Update Posted (Estimate)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 9, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAT3-06-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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