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Prostate CancerPhase 3SPERANCT00450970

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

A Phase 3 study testing Oral Satraplatin in people with Prostate Cancer, run by Agennix at 121 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Oral Satraplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
344 participants
Where
121 sitesUnited States
Study dates
Feb 2007to Dec 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

121 sites in 1 country.

121 sites in 1 country

United States121 sites

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • McFarland Clinic PC

    Ames, Iowa, 50010

  • Pacific Cancer Medical Center, Inc

    Anaheim, California, 92801

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Notheast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Medical Oncology Assoc. of Augusta, PC

    Augusta, Georgia, 30901

  • Texas Oncology Cancer Center, PA

    Austin, Texas, 78731

  • Lone Star Oncology Consultants

    Austin, Texas, 78759

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Hematology Oncology Assoc. of W. Suffolk, PC

    Bay Shore, New York, 11706

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • The Billings Clinic

    Billings, Montana, 59101

  • Carraway Cancer Clinic

    Birmingham, Alabama, 35234

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35235

  • Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • Florida Cancer Specalists

    Bradenton, Florida, 34209

  • Oncology Associates of Bridgeport

    Bridgeport, Connecticut, 06611

  • East Valley Hematology Oncology Medical Group

    Burbank, California, 91505

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Tricounty Hem/Onc Associates

    Canton, Ohio, 44718

  • Iowa Blood and Cancer Care, PLC

    Cedar Rapids, Iowa, 52402

  • University of Chicago

    Chicago, Illinois, 60637

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Rocky Mountain Cancer Center

    Colorado Springs, Colorado, 80909

  • Columbia Comprehensive Cancer Care Center

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • Mid-Ohio Oncology/Hematology

    Columbus, Ohio, 43219

  • Hematology-Oncology Consultants, Inc

    Columbus, Ohio, 43235

  • The Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78463

  • Heartland Oncology & Hematology, LLP

    Council Bluffs, Iowa, 51503

  • Mitchell Medical Clinic

    Daingerfield, Texas, 75638

  • Center for Oncology Research and Treatment

    Dallas, Texas, 75230

  • Texas Oncology

    Dallas, Texas, 75231

  • Clinical Oncology & Hematology, LLP

    Dallas, Texas, 75235

  • Dallas Oncology Consultants, PA

    Dallas, Texas, 75237

  • GA Urology

    Decatur, Georgia, 30033

  • Texas Cancer Center

    Denton, Texas, 76210

  • Cancer Care at St. Claire's

    Denville, New Jersey, 07834

  • North Shore Hematology Oncology Assoc.

    East Setauket, New York, 11733

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Medical Specialists of Fairfield, LLC

    Fairfield, Connecticut, 06284

  • MeritCare Clinical Research

    Fargo, North Dakota, 58122

  • Carolina Health Care

    Florence, South Carolina, 29501

  • Florida Cancer Care Specialists-Fort Myers Summerlin Office

    Fort Myers, Florida, 33908

  • Fort Wayne Medical Oncology Hematology, Inc.

    Fort Wayne, Indiana, 46815

  • Cancer Care Centers of South Texas

    Fredericksburg, Texas, 78624

  • Gainesville Hematology Oncology Associates

    Gainesville, Florida, 32605

  • Medical & Surgical Spealists, LLC

    Galesburg, Illinois, 61401

  • Gaston Hematology and Oncology

    Gastonia, North Carolina, 28054

  • Mid-South Cancer Center, PC

    Germantown, Tennessee, 38138

  • Mid-South Cancer Center

    Germantown, Tennessee, 38138

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Saint Francis Memoiral Hospital

    Grand Island, Nebraska, 68803

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49546

  • Green Bay Oncology, Ltd.

    Green Bay, Wisconsin, 54301

  • The Center for Clinical Research

    Hagerstown, Maryland, 21740

  • Mahendra M. Shah, MD, FACP

    Hammond, Indiana, 46320

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Jackson Oncology Associates

    Jackson, Mississippi, 39202

  • ICON

    Jacksonville, Florida, 32256

  • McLeod Cancer and Blood Center

    Johnson City, Tennessee, 37604

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • Kalamazoo Hematology and Oncology

    Kalamazoo, Michigan, 49048

  • Kingsport Hematology Oncology

    Kingsport, Tennessee, 37660

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Lancaster Cancer Center, Ltd.

    Lancaster, Pennsylvania, 17601

  • Suburban Hematology-Oncology Assoc., PC

    Lawrenceville, Georgia, 30045

  • Nebraska Hematology-Oncology,PC

    Lincoln, Nebraska, 68506

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Drs.Caroll, Sheth and Raghavan

    Louisville, Kentucky, 40215

  • Davis, Posteraro, and Wasser, MDs, LLP

    Manchester, Connecticut, 06040

  • Ohio Cancer Specialists

    Mansfield, Ohio, 44907

  • Urology Associates, S.C.

    Mattoon, Illinois, 61938

  • MIMA Century Research Assoc.

    Melbourne, Florida, 32901

  • Boston Baskin Cancer Group D/B/A/ UTCI

    Memphis, Tennessee, 38104

  • Marc I. Saltzman

    Miami, Florida, 33138

  • Allison Cancer Center

    Midland, Texas, 79701

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • North Valley Hematology/Oncology Medical Group

    Mission Hills, California, 91345

  • Michael Harris MD

    Mission Viejo, California, 92691

  • Hematology Oncology Associates of Northern New Jersey

    Morristown, New Jersey, 07960

  • Cancer Care Centers of South Texas

    New Braunfels, Texas, 78130

  • Newport Cancer Care Medical Assoc., Inc.

    Newport Beach, California, 92663

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Mid-Illinois Hematology and Oncology Assoc., LTD

    Normal, Illinois, 61761

  • Whittigham Cancer Center at Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73112

  • Cancer Specialists of Oklahoma

    Oklahoma City, Oklahoma, 73112

  • Medical Oncology Care Associates

    Orange, California, 92868

  • Mid-Florida Hematology & Oncology Centers

    Orange City, Florida, 32763

  • Sacred Heart Hospital Cancer Research

    Pensacola, Florida, 32504

  • Oncology Hematology Associates of Central IL, PC

    Peoria, Illinois, 61615

  • Greater Philadelphia Cancer Center

    Philadelphia, Pennsylvania, 19114

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980

  • Cancer Center of North Carolina

    Raleigh, North Carolina, 27614

  • Desert Cancer Center

    Rancho Mirage, California, 92270

  • Associates in Oncology/Hematology

    Rockville, Maryland, 20850

  • Sharp Clinical Oncology Research

    San Diego, California, 92123

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • Santa Barbara Hematology Oncology Medical Group

    Santa Barbara, California, 93105

  • Santa Barbara Hemotology

    Santa Barbara, California, 93105

  • Sacred Heart Medical Center - Providence Cancer Care Center

    Spokane, Washington, 99204

  • St. Johns Mercy Medical Center

    St Louis, Missouri, 63141

  • The Center for Cancer Care & Research

    St Louis, Missouri, 63141

  • Hematology Oncology

    Stamford, Connecticut, 06902

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • Stockton Hematology Oncology Medical Group

    Stockton, California, 95204

  • Connecticut Oncology & Hematology, LLP

    Torrington, Connecticut, 06790

  • Sierra Nevada Oncology

    Truckee, California, 96161

  • Cancer Care Associates

    Tulsa, Oklahoma, 73146

  • NW MS Hem/Onc (Tupelo)

    Tupelo, Mississippi, 38801

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98684

  • Cedar Valley Medical Specialists

    Waterloo, Iowa, 50702

  • Northern Valley Medical

    Westwood, New Jersey, 07675

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Oral Satraplatin
Keywords
Hormone Refractory Prostate Cancer (HRPC), Hormone Refractory Prostate Cancer, Unlimited Prior Cytotoxic Chemotherapy Regimens
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral SatraplatinDrug

    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.

Study groups in NCT00450970
Study groupRoleWhat they receive
1ExperimentalPrednisone 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.
Receives: Drug: Oral Satraplatin
2ExperimentalPrednisone (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.
Receives: Drug: Oral Satraplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Patient evaluation by MD at baseline to determine eligibility.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionMar 2009
  4. Study completionDec 2009

Why it stopped: Sponsor decided to discontinue study drug development.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00450970
Sponsor's protocol ID
SAT3-06-04
Acronym
SPERA
Status last verified
Aug 2012
First submitted
20 Mar 2007
Last updated
17 Aug 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral Satraplatin in people with Prostate Cancer, run by Agennix at 121 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decided to discontinue study drug development.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00450970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2012.

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