Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)
NCT ID: NCT00450970
Last Updated: 2012-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
344 participants
INTERVENTIONAL
2007-02-28
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Agennix
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe Pultar, MD
Role: STUDY_DIRECTOR
GPC Biotech Inc.
Locations
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Carraway Cancer Clinic
Birmingham, Alabama, United States
Birmingham Hematology and Oncology
Birmingham, Alabama, United States
Urology Centers of Alabama
Homewood, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
Clopton Clinic
Jonesboro, Arkansas, United States
Pacific Cancer Medical Center, Inc
Anaheim, California, United States
East Valley Hematology Oncology Medical Group
Burbank, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
North Valley Hematology/Oncology Medical Group
Mission Hills, California, United States
Michael Harris MD
Mission Viejo, California, United States
Newport Cancer Care Medical Assoc., Inc.
Newport Beach, California, United States
Medical Oncology Care Associates
Orange, California, United States
Desert Cancer Center
Rancho Mirage, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Santa Barbara Hematology Oncology Medical Group
Santa Barbara, California, United States
Santa Barbara Hemotology
Santa Barbara, California, United States
Stockton Hematology Oncology Medical Group
Stockton, California, United States
Sierra Nevada Oncology
Truckee, California, United States
Rocky Mountain Cancer Center
Colorado Springs, Colorado, United States
Oncology Associates of Bridgeport
Bridgeport, Connecticut, United States
Medical Specialists of Fairfield, LLC
Fairfield, Connecticut, United States
Davis, Posteraro, and Wasser, MDs, LLP
Manchester, Connecticut, United States
Whittigham Cancer Center at Norwalk Hospital
Norwalk, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Hematology Oncology
Stamford, Connecticut, United States
Connecticut Oncology & Hematology, LLP
Torrington, Connecticut, United States
Center for Hematology-Oncology
Boca Raton, Florida, United States
Florida Cancer Specalists
Bradenton, Florida, United States
Florida Cancer Care Specialists-Fort Myers Summerlin Office
Fort Myers, Florida, United States
Gainesville Hematology Oncology Associates
Gainesville, Florida, United States
ICON
Jacksonville, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
MIMA Century Research Assoc.
Melbourne, Florida, United States
Marc I. Saltzman
Miami, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Mid-Florida Hematology & Oncology Centers
Orange City, Florida, United States
Sacred Heart Hospital Cancer Research
Pensacola, Florida, United States
Florida Cancer Specialists
Port Charlotte, Florida, United States
Notheast Georgia Cancer Care, LLC
Athens, Georgia, United States
Medical Oncology Assoc. of Augusta, PC
Augusta, Georgia, United States
GA Urology
Decatur, Georgia, United States
Suburban Hematology-Oncology Assoc., PC
Lawrenceville, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Medical & Surgical Spealists, LLC
Galesburg, Illinois, United States
Urology Associates, S.C.
Mattoon, Illinois, United States
Mid-Illinois Hematology and Oncology Assoc., LTD
Normal, Illinois, United States
Oncology Hematology Associates of Central IL, PC
Peoria, Illinois, United States
Fort Wayne Medical Oncology Hematology, Inc.
Fort Wayne, Indiana, United States
Mahendra M. Shah, MD, FACP
Hammond, Indiana, United States
McFarland Clinic PC
Ames, Iowa, United States
Iowa Blood and Cancer Care, PLC
Cedar Rapids, Iowa, United States
Heartland Oncology & Hematology, LLP
Council Bluffs, Iowa, United States
Cedar Valley Medical Specialists
Waterloo, Iowa, United States
Drs.Caroll, Sheth and Raghavan
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
The Center for Clinical Research
Hagerstown, Maryland, United States
Associates in Oncology/Hematology
Rockville, Maryland, United States
Lahey Clinic
Burlington, Massachusetts, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, United States
Jackson Oncology Associates
Jackson, Mississippi, United States
NW MS Hem/Onc (Tupelo)
Tupelo, Mississippi, United States
Columbia Comprehensive Cancer Care Center
Columbia, Missouri, United States
Ellis Fischel Cancer Center
Columbia, Missouri, United States
St. Johns Mercy Medical Center
St Louis, Missouri, United States
The Center for Cancer Care & Research
St Louis, Missouri, United States
The Billings Clinic
Billings, Montana, United States
Saint Francis Memoiral Hospital
Grand Island, Nebraska, United States
Nebraska Hematology-Oncology,PC
Lincoln, Nebraska, United States
Cancer Care at St. Claire's
Denville, New Jersey, United States
Hematology Oncology Associates of Northern New Jersey
Morristown, New Jersey, United States
Northern Valley Medical
Westwood, New Jersey, United States
Hematology Oncology Assoc. of W. Suffolk, PC
Bay Shore, New York, United States
The Mary Imogene Bassett Hospital
Cooperstown, New York, United States
North Shore Hematology Oncology Assoc.
East Setauket, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
Gaston Hematology and Oncology
Gastonia, North Carolina, United States
Cancer Center of North Carolina
Raleigh, North Carolina, United States
MeritCare Clinical Research
Fargo, North Dakota, United States
Trinity Cancer Care Center
Minot, North Dakota, United States
Tricounty Hem/Onc Associates
Canton, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
Mid-Ohio Oncology/Hematology
Columbus, Ohio, United States
Hematology-Oncology Consultants, Inc
Columbus, Ohio, United States
Ohio Cancer Specialists
Mansfield, Ohio, United States
Cancer Care Associates
Oklahoma City, Oklahoma, United States
Cancer Specialists of Oklahoma
Oklahoma City, Oklahoma, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, United States
Lancaster Cancer Center, Ltd.
Lancaster, Pennsylvania, United States
Greater Philadelphia Cancer Center
Philadelphia, Pennsylvania, United States
Carolina Health Care
Florence, South Carolina, United States
Mid-South Cancer Center, PC
Germantown, Tennessee, United States
Mid-South Cancer Center
Germantown, Tennessee, United States
The Jones Clinic
Germantown, Tennessee, United States
McLeod Cancer and Blood Center
Johnson City, Tennessee, United States
Kingsport Hematology Oncology
Kingsport, Tennessee, United States
Boston Baskin Cancer Group D/B/A/ UTCI
Memphis, Tennessee, United States
Harrington Cancer Center
Amarillo, Texas, United States
Texas Oncology Cancer Center, PA
Austin, Texas, United States
Lone Star Oncology Consultants
Austin, Texas, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, United States
Mitchell Medical Clinic
Daingerfield, Texas, United States
Center for Oncology Research and Treatment
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Clinical Oncology & Hematology, LLP
Dallas, Texas, United States
Dallas Oncology Consultants, PA
Dallas, Texas, United States
Texas Cancer Center
Denton, Texas, United States
Cancer Care Centers of South Texas
Fredericksburg, Texas, United States
Allison Cancer Center
Midland, Texas, United States
Cancer Care Centers of South Texas
New Braunfels, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Sacred Heart Medical Center - Providence Cancer Care Center
Spokane, Washington, United States
Northwest Cancer Specialists, PC
Vancouver, Washington, United States
Green Bay Oncology, Ltd.
Green Bay, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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SAT3-06-04
Identifier Type: -
Identifier Source: org_study_id