A Multicenter, Single-arm, Open Label Treatment Protocol to Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) APPROVED MDV3100 (ENZALUTAMIDE) FOR
SALE TO THE PUBLIC, ENROLLMENT IS CLOSED IN THE UNITED STATES.
ENROLLMENT IS OPEN IN CANADA.
The expanded access treatment protocol is being conducted while marketing approval of
enzalutamide is being sought. There is no age requirement.
Subjects will complete visits on Day 1, Week 4, Week 12 and then every subsequent 12 weeks
until discontinued from the study.
The study will end if enzalutamide is approved for sale to the public by the country's
health authority (commercially available) or if the sponsor otherwise decides or is required
to end the study. If a subject would like to receive enzalutamide after the study ends, he
and the doctor will decide if he should receive a prescription for enzalutamide, with a goal
of avoiding any interruption in treatment.
Expanded Access
N/A
United States: Food and Drug Administration
9785-CL-0401
NCT01606982
Name | Location |
---|---|
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
Jackson Oncology Associates, PLLC | Jackson, Mississippi 39202 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Oregon Health & Science University | Portland, Oregon 97201 |
Northwest Medical Specialties, PLLC | Tacoma, Washington 98405 |
Alaska Clinical Research Center, LLC | Anchorage, Alaska 99508 |
AccuMed Research Associates | Garden City, New York 11530 |
Northwest Georgia Oncology Centers, P.C. | Marietta, Georgia 30060 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Stanford University Cancer Center | Stanford, California 94305 |
Cancer Centers of North Carolina | Raleigh, North Carolina 27607 |
Charleston Hematology Oncology Associates, PA | Charleston, South Carolina 29403 |
Peachtree Hematology-Oncology Consultants, P.C. | Atlanta, Georgia 30309 |
The Jones Clinic, Pc | Germantown, Tennessee 38138 |
Southwestern Regional Medical Center | Tulsa, Oklahoma 74133 |
Redwood Regional Medical Group, Inc. | Santa Rosa, California 95403 |
Pinnacle Oncology Hematology | Scottsdale, Arizona 85258 |
Illinois CancerCare, P.C. | Bloomington, Illinois 61701 |
Georgetown Lombardi Comprehensive Cancer Center | Washington, District of Columbia 20007 |
Ronald H. Yanagihara, MD - | Gilroy, California 95020 |
Tower Urology / Tower Research Institute | Los Angeles, California 90048 |
Prostate Oncology Specialist Inc. | Marina Del Rey, California 90292 |
Ocala Oncolgy Center | Ocala, Florida 34471 |
Investigative Clinical Research of Indiana, LLC - | Indianapolis, Indiana 46260 |
Metairie Oncologist, LLC | Metairie, Louisiana 70006 |
Nebraska Hemotology - Oncology PPC | Lincoln, Nebraska 68506 |
New Hampshire Oncology Hematology PA | Hooksett, New Hampshire 03106 |
UT Southwesern Medical Center | Dallas, Texas 75390 |
GU Research Network | Omaha, Nebraska 68130 |
George Washington University Medical Faculty Assoc | Washington DC, District of Columbia 20037 |
Comprehensive Cancer Centers of NV | Las Vegas, Nevada 89169 |
Tulsa Cancer Institute | Tulsa, Oklahoma 74136 |