A Randomized Double-Blind Phase 3 Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®) in Combination Versus PLD in Participants With Platinum-Resistant Ovarian Cancer
This is a Phase 3 clinical trial to evaluate the efficacy and safety of the combination of
EC145 and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil® and
outside the United States as Caelyx®) compared to PLD and placebo. Enrollment of 640
patients including approximately 500 that are folate receptor positive is planned.
EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin
receptor (FR) that is not generally found on normal cells. Experimental evidence shows that
this target receptor is expressed on virtually all ovarian cancers. Early clinical evidence
in a small number of Phase I participants, in a subset of participants in a completed
single-arm Phase II study, and interim data from an ongoing randomized Phase 2 study
(PRECEDENT) suggests that EC145 may have antitumor effect in women with platinum-resistant
ovarian cancer and that EC145 alone and in combination with PLD is generally well-tolerated.
This evidence suggests that EC145 may be useful as chemotherapy against platinum-resistant
ovarian cancer.
All participants will undergo imaging with the FR-targeting investigational diagnostic agent
EC20 during the screening period to assess binding of the imaging agent EC20 to tumors. This
non-invasive procedure will provide additional information on the utility of using EC20
imaging to identify subjects with the FR molecular "target" prior to treatment with EC145
therapy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression-free survival based on investigator assessment using RECIST v1.1.
Progression is assessed at 6 week intervals through Week 24 and at 8 week intervals thereafter.
up to 26 months
No
Binh Nguyen, MD
Study Director
Endocyte
United States: Food and Drug Administration
EC-FV-06
NCT01170650
April 2011
May 2015
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Northwestern Memorial Hospital | Chicago, Illinois 60611 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Texas Oncology, P.A. | Dallas, Texas 75246 |
Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Toledo Hospital | Toledo, Ohio 43606 |
Mayo Clinic | Jacksonville, Florida 32224 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Bay Regional Medical Center | Bay City, Michigan 48708 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Southeastern Gynecologic Oncology | Decatur, Georgia 30033 |
Medical College of Georgia | Augusta, Georgia 30912 |
University of Washington | Seattle, Washington 98195 |
University of California, San Francisco | San Francisco, California 94143 |
Duke University Medical Center | Durham, North Carolina 27710 |
Kaiser Permanente Medical Center | Vallejo, California 94589 |
California Pacific Medical Center | San Francisco, California 94115 |
Oncology Associates of San Diego | San Diego, California 92123 |
Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
Texas Oncology | Dallas, Texas |
St. Vincent Gynecologic Oncology | Indianapolis, Indiana 46260 |
Chattanooga GYN Oncology | Chattanooga, Tennessee 37403 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Yale University School Of Medicine | New Haven, Connecticut 06520 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Nevada Cancer Institute | Las Vegas, Nevada 89135 |
Chattanooga's Program in Women's Oncology | Chattanooga, Tennessee 37403 |
University of Maryland Medical Center | Baltimore, Maryland 21201-1595 |
Mayo Clinic Arizona | Scottsdale, Arizona 85259 |
Northside Hospital | Atlanta, Georgia 30342 |
Multicare Health System | Tacoma, Washington 98415 |
Cancer and Blood Disease Center | Lecanto, Florida 34461 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
Karmanos Cancer Center | Detroit, Michigan 48201 |
Schwartz Gynecologic Oncology, PLLC | Babylon, New York 11702 |
Mount Clemens Regional Medical Center | Mount Clemens, Michigan 48043 |
Gynecologic Oncology Associates, Inc | Hollywood, Florida 33020 |
Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |
Columbia Basin Hematology and Oncology | Kennewick, Washington 99336 |
Center for Blood and Cancer Disorders | Bethesda, Maryland 20817 |
North American Research Institute | West Covina, California 91790 |
Altus Research | Lake Worth, Florida 33461 |
Meritus Center For Clinical Research | Hagerstown, Maryland 21740 |
Scripps Clinical Research Services | La Jolla, California 92037 |
University of Arizona - Arizona Cancer Center | Tuscon, Arizona 85724 |
Marin Caner Care, Inc. | Greenbrae, California 94904 |
PMK Medical Group, Inc., dba Ventura County Hematology Oncology Specialists | Oxnard, California 93030 |
Stanford University Medical Center - Cancer Center | Standford, California 94305 |
Kaiser Permanente Vallejo Medical Center | Vallejo, California 94589 |
St. Vincent's Medcial Center | Bridgeport, Connecticut 06606 |
Palm Beach Cancer Institute - Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
Sudarshan K. Sharma, LTD | Hinsdale, Illinois 60521 |
St. Francis Medical Group Gynecologic Oncology of Indiana | Indianapolis, Indiana 46237 |
University of Louisville James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
Singh & Arora Onc/Hem, PC | Flint, Michigan 48532 |
MSU Breslin Cancer Center | Lansing, Michigan 48910 |
Lapeer Regional Medical Center | Lapeer, Michigan 48446 |
Providence Hospital and Medical Center | Southfield, Michigan 48075 |
Bozeman Deaconess Hospital Cancer Center | Bozeman, Montana 59715 |
Holy Name Medical Center | Teaneck, New Jersey 07666 |
Southwest Gynecologic Oncology Associates | Albuquerque, New Mexico 87106 |
Greater Cincinnati OB/GYN, Inc | Cincinnati, Ohio 45267 |
Medical University of South Carolina, Dept. OB/GYN | Charleston, South Carolina 29425 |
Texas Oncology- Central Austin Cancer Center | Austin, Texas 78731 |
Mary Crowley Medical City Clinic | Dallas, Texas 75230 |
Texas Oncology-Dallas, PA Presbyterian | Dallas, Texas 75231 |