|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | GPC Biotech |
|---|---|
| Information provided by: | GPC Biotech |
| ClinicalTrials.gov Identifier: | NCT00450970 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Oral Satraplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety 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) |
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | December 2007 |
*****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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Urology Centers of Alabama | |
| Homewood, Alabama, United States, 35209 | |
| Carraway Cancer Clinic | |
| Birmingham, Alabama, United States, 35234 | |
| Birmingham Hematology and Oncology | |
| Birmingham, Alabama, United States, 35235 | |
| United States, Alaska | |
| Providence Alaska Medical Center | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arkansas | |
| Clopton Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| Genesis Cancer Center | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, California | |
| Medical Oncology Care Associates | |
| Orange, California, United States, 92868 | |
| Stockton Hematology Oncology Medical Group | |
| Stockton, California, United States, 95204 | |
| Santa Barbara Hematology Oncology Medical Group | |
| Santa Barbara, California, United States, 93105 | |
| Pacific Hematology Oncology Associates | |
| San Francisco, California, United States, 94115 | |
| North Valley Hematology/Oncology Medical Group | |
| Mission Hills, California, United States, 91345 | |
| Sharp Clinical Oncology Research | |
| San Diego, California, United States, 92123 | |
| Desert Cancer Center | |
| Rancho Mirage, California, United States, 92270 | |
| Sierra Nevada Oncology | |
| Truckee, California, United States, 96161 | |
| Pacific Cancer Medical Center, Inc | |
| Anaheim, California, United States, 92801 | |
| Newport Cancer Care Medical Assoc., Inc. | |
| Newport Beach, California, United States, 92663 | |
| Michael Harris MD | |
| Mission Viejo, California, United States, 92691 | |
| Pacific Shores Medical Group | |
| Long Beach, California, United States, 90813 | |
| East Valley Hematology Oncology Medical Group | |
| Burbank, California, United States, 91505 | |
| Santa Barbara Hemotology | |
| Santa Barbara, California, United States, 93105 | |
| United States, Colorado | |
| Rocky Mountain Cancer Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| United States, Connecticut | |
| Hematology Oncology | |
| Stamford, Connecticut, United States, 06902 | |
| Eastern Connecticut Hematology and Oncology Associates | |
| Norwich, Connecticut, United States, 06360 | |
| Oncology Associates of Bridgeport | |
| Bridgeport, Connecticut, United States, 06611 | |
| Davis, Posteraro, and Wasser, MDs, LLP | |
| Manchester, Connecticut, United States, 06040 | |
| Medical Specialists of Fairfield, LLC | |
| Fairfield, Connecticut, United States, 06284 | |
| Whittigham Cancer Center at Norwalk Hospital | |
| Norwalk, Connecticut, United States, 06856 | |
| Connecticut Oncology & Hematology, LLP | |
| Torrington, Connecticut, United States, 06790 | |
| United States, Florida | |
| Marc I. Saltzman | |
| Miami, Florida, United States, 33138 | |
| Florida Cancer Care Specialists-Fort Myers Summerlin Office | |
| Fort Myers, Florida, United States, 33908 | |
| ICON | |
| Jacksonville, Florida, United States, 32256 | |
| Gainesville Hematology Oncology Associates | |
| Gainesville, Florida, United States, 32605 | |
| Lakeland Regional Medical Center | |
| Lakeland, Florida, United States, 33805 | |
| Sacred Heart Hospital Cancer Research | |
| Pensacola, Florida, United States, 32504 | |
| Florida Cancer Specalists | |
| Bradenton, Florida, United States, 34209 | |
| Center for Hematology-Oncology | |
| Boca Raton, Florida, United States, 33486 | |
| Mid-Florida Hematology & Oncology Centers | |
| Orange City, Florida, United States, 32763 | |
| Ocala Oncology Center | |
| Ocala, Florida, United States, 34474 | |
| Florida Cancer Specialists | |
| Port Charlotte, Florida, United States, 33980 | |
| Florida Cancer Specialists | |
| Port Charlotte, Florida, United States, 33980 | |
| MIMA Century Research Assoc. | |
| Melbourne, Florida, United States, 32901 | |
| United States, Georgia | |
| GA Urology | |
| Decatur, Georgia, United States, 30033 | |
| Suburban Hematology-Oncology Assoc., PC | |
| Lawrenceville, Georgia, United States, 30045 | |
| Notheast Georgia Cancer Care, LLC | |
| Athens, Georgia, United States, 30607 | |
| Medical Oncology Assoc. of Augusta, PC | |
| Augusta, Georgia, United States, 30901 | |
| United States, Illinois | |
| Urology Associates, S.C. | |
| Mattoon, Illinois, United States, 61938 | |
| Mid-Illinois Hematology and Oncology Assoc., LTD | |
| Normal, Illinois, United States, 61761 | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Medical & Surgical Spealists, LLC | |
| Galesburg, Illinois, United States, 61401 | |
| Oncology Hematology Associates of Central IL, PC | |
| Peoria, Illinois, United States, 61615 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology Hematology, Inc. | |
| Fort Wayne, Indiana, United States, 46815 | |
| Mahendra M. Shah, MD, FACP | |
| Hammond, Indiana, United States, 46320 | |
| United States, Iowa | |
| Heartland Oncology & Hematology, LLP | |
| Council Bluffs, Iowa, United States, 51503 | |
| Cedar Valley Medical Specialists | |
| Waterloo, Iowa, United States, 50702 | |
| Iowa Blood and Cancer Care, PLC | |
| Cedar Rapids, Iowa, United States, 52402 | |
| McFarland Clinic PC | |
| Ames, Iowa, United States, 50010 | |
| United States, Kentucky | |
| Drs.Caroll, Sheth and Raghavan | |
| Louisville, Kentucky, United States, 40215 | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| The Center for Clinical Research | |
| Hagerstown, Maryland, United States, 21740 | |
| Associates in Oncology/Hematology | |
| Rockville, Maryland, United States, 20850 | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Massachusetts | |
| Lahey Clinic | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Michigan | |
| Kalamazoo Hematology and Oncology | |
| Kalamazoo, Michigan, United States, 49048 | |
| Cancer & Hematology Centers of Western Michigan | |
| Grand Rapids, Michigan, United States, 49546 | |
| United States, Mississippi | |
| NW MS Hem/Onc (Tupelo) | |
| Tupelo, Mississippi, United States, 38801 | |
| Jackson Oncology Associates | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center | |
| Columbia, Missouri, United States, 65203 | |
| Columbia Comprehensive Cancer Care Center | |
| Columbia, Missouri, United States, 65201 | |
| The Center for Cancer Care & Research | |
| St. Louis, Missouri, United States, 63141 | |
| St. Johns Mercy Medical Center | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Montana | |
| The Billings Clinic | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Nebraska Hematology-Oncology,PC | |
| Lincoln, Nebraska, United States, 68506 | |
| Saint Francis Memoiral Hospital | |
| Grand Island, Nebraska, United States, 68803 | |
| United States, New Jersey | |
| Cancer Care at St. Claire's | |
| Denville, New Jersey, United States, 07834 | |
| Northern Valley Medical | |
| Westwood, New Jersey, United States, 07675 | |
| Hematology Oncology Associates of Northern New Jersey | |
| Morristown, New Jersey, United States, 07960 | |
| United States, New York | |
| Richmond University Medical Center | |
| Staten Island, New York, United States, 10310 | |
| North Shore Hematology Oncology Assoc. | |
| E. Setauket, New York, United States, 11733 | |
| Hematology Oncology Assoc. of W. Suffolk, PC | |
| Bay Shore, New York, United States, 11706 | |
| The Mary Imogene Bassett Hospital | |
| Cooperstown, New York, United States, 13326 | |
| United States, North Carolina | |
| Gaston Hematology and Oncology | |
| Gastonia, North Carolina, United States, 28054 | |
| Cancer Center of North Carolina | |
| Raleigh, North Carolina, United States, 27614 | |
| United States, North Dakota | |
| MeritCare Clinical Research | |
| Fargo, North Dakota, United States, 58122 | |
| Trinity Cancer Care Center | |
| Minot, North Dakota, United States, 58701 | |
| United States, Ohio | |
| Tricounty Hem/Onc Associates | |
| Canton, Ohio, United States, 44718 | |
| Hematology-Oncology Consultants, Inc | |
| Columbus, Ohio, United States, 43235 | |
| Ohio Cancer Specialists | |
| Mansfield, Ohio, United States, 44907 | |
| The Christ Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| Mid-Ohio Oncology/Hematology | |
| Columbus, Ohio, United States, 43219 | |
| United States, Oklahoma | |
| Cancer Care Associates | |
| Tulsa, Oklahoma, United States, 73146 | |
| Cancer Care Associates | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Cancer Specialists of Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Pennsylvania | |
| Greater Philadelphia Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19114 | |
| Lancaster Cancer Center, Ltd. | |
| Lancaster, Pennsylvania, United States, 17601 | |
| Ephrata Cancer Center | |
| Ephrata, Pennsylvania, United States, 17522 | |
| United States, South Carolina | |
| Carolina Health Care | |
| Florence, South Carolina, United States, 29501 | |
| United States, Tennessee | |
| Kingsport Hematology Oncology | |
| Kingsport, Tennessee, United States, 37660 | |
| The Jones Clinic | |
| Germantown, Tennessee, United States, 38138 | |
| McLeod Cancer and Blood Center | |
| Johnson City, Tennessee, United States, 37604 | |
| Mid-South Cancer Center | |
| Germantown, Tennessee, United States, 38138 | |
| Mid-South Cancer Center, PC | |
| Germantown, Tennessee, United States, 38138 | |
| Boston Baskin Cancer Group D/B/A/ UTCI | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Center for Oncology Research and Treatment | |
| Dallas, Texas, United States, 75230 | |
| Lone Star Oncology Consultants | |
| Austin, Texas, United States, 78759 | |
| Coastal Bend Cancer Center | |
| Corpus Christi, Texas, United States, 78463 | |
| Texas Oncology Cancer Center, PA | |
| Austin, Texas, United States, 78731 | |
| Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| Cancer Care Centers of South Texas | |
| New Braunfels, Texas, United States, 78130 | |
| Texas Oncology | |
| Dallas, Texas, United States, 75231 | |
| Dallas Oncology Consultants, PA | |
| Dallas, Texas, United States, 75237 | |
| Texas Cancer Center | |
| Denton, Texas, United States, 76210 | |
| Cancer Care Centers of South Texas | |
| Fredericksburg, Texas, United States, 78624 | |
| Clinical Oncology & Hematology, LLP | |
| Dallas, Texas, United States, 75235 | |
| Allison Cancer Center | |
| Midland, Texas, United States, 79701 | |
| Mitchell Medical Clinic | |
| Daingerfield, Texas, United States, 75638 | |
| United States, Utah | |
| Northern Utah Associates | |
| Ogden, Utah, United States, 84403 | |
| United States, Virginia | |
| Virginia Oncology Associates | |
| Newport News, Virginia, United States, 23606 | |
| Peninsula Cancer Institute | |
| Newport News, Virginia, United States, 23601 | |
| United States, Washington | |
| Northwest Cancer Specialists, PC | |
| Vancouver, Washington, United States, 98684 | |
| Sacred Heart Medical Center - Providence Cancer Care Center | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Green Bay Oncology, Ltd. | |
| Green Bay, Wisconsin, United States, 54301 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Director: | Philippe Pultar, MD | GPC Biotech Inc. |
More Information
| Study ID Numbers: | SAT3-06-04 |
| Study First Received: | March 20, 2007 |
| Last Updated: | January 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00450970 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hormone Refractory Prostate Cancer (HRPC) Hormone Refractory Prostate Cancer Unlimited Prior Cytotoxic Chemotherapy Regimens |
|
Anti-Inflammatory Agents Prednisone Satraplatin Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Urogenital Neoplasms Genital Diseases, Male Glucocorticoids Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |
