TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
NCT ID: NCT01493505
Last Updated: 2017-02-23
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
1015 participants
INTERVENTIONAL
2012-01-31
2016-12-31
Brief Summary
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TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer
NCT01204749
AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)
NCT01281254
Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer
NCT01253681
Phase 2 AMG 386 in Comb. Paclitaxel for Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer
NCT00479817
Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer
NCT00718523
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo Paclitaxel Carboplatin
Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
AMG 386 Placebo
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
AMG 386
AMG 386 Paclitaxel Carboplatin
AMG 386
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Interventions
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AMG 386
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
AMG 386 Placebo
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Eligibility Criteria
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Inclusion Criteria
* Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
* Subjects with FIGO Stage IIIC or IV disease must either:
* Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
* Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
* ECOG performance status of 0 or 1
* Adequate bone marrow, renal and hepatic function
Exclusion Criteria
* Previous abdominal and/or pelvic external beam radiotherapy
* History of central nervous metastasis
* History of arterial or venous thromboembolism within 12 months prior to randomization
* Clinically significant cardiovascular disease within 12 months prior to randomization
18 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Namur, , Belgium
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Ostend, , Belgium
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Sint-Niklaas, , Belgium
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Turnhout, , Belgium
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Wilrijk, , Belgium
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Yvoir, , Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Kingston, Ontario, Canada
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Anchorage, Alaska, United States
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Gilbert, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Berkeley, California, United States
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Burbank, California, United States
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Concord, California, United States
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Corona, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Oxnard, California, United States
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Rancho Mirage, California, United States
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Sacramento, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Englewood, Colorado, United States
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Bridgeport, Connecticut, United States
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Farmington, Connecticut, United States
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Hartford, Connecticut, United States
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New Britain, Connecticut, United States
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Stamford, Connecticut, United States
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Clearwater, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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Gainesville, Georgia, United States
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Macon, Georgia, United States
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Savannah, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Evanston, Illinois, United States
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Hinsdale, Illinois, United States
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Joliet, Illinois, United States
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Maywood, Illinois, United States
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Oak Lawn, Illinois, United States
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Park Ridge, Illinois, United States
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Urbana, Illinois, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Munster, Indiana, United States
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South Bend, Indiana, United States
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Ames, Iowa, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Edgewood, Kentucky, United States
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Lexington, Kentucky, United States
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Covington, Louisiana, United States
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Lafayette, Louisiana, United States
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Scarborough, Maine, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Burlington, Massachusetts, United States
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Danvers, Massachusetts, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Jackson, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Lebanon, New Hampshire, United States
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Hackensack, New Jersey, United States
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Neptune City, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Brightwaters, New York, United States
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Buffalo, New York, United States
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Jamaica, New York, United States
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Lake Success, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Asheville, North Carolina, United States
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Burlington, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Durham, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Akron, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Kettering, Ohio, United States
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Mayfield Heights, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bend, Oregon, United States
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Abington, Pennsylvania, United States
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Bethlehem, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Radnor, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Greenville, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Chattanooga, Tennessee, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Galveston, Texas, United States
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The Woodlands, Texas, United States
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Ogden, Utah, United States
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Burlington, Vermont, United States
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Annandale, Virginia, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Winchester, Virginia, United States
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Woodbridge, Virginia, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Wenatchee, Washington, United States
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Green Bay, Wisconsin, United States
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Marshfield, Wisconsin, United States
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Oshkosh, Wisconsin, United States
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Sheboygan, Wisconsin, United States
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Waukesha, Wisconsin, United States
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Wausau, Wisconsin, United States
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West Allis, Wisconsin, United States
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Graz, , Austria
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Bonheiden, , Belgium
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Brasschaat, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Duffel, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Libramont, , Belgium
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Liège, , Belgium
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London, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Herlev, , Denmark
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København Ø, , Denmark
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Roskilde, , Denmark
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Berlin, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Düsseldorf, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Essen, , Germany
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Frankfurt am Main, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Konstanz, , Germany
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Leipzig, , Germany
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Ludwigsburg, , Germany
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München, , Germany
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München, , Germany
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München, , Germany
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Oldenburg, , Germany
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Ravensburg, , Germany
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Rostock, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Athens, , Greece
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Larissa, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Kowloon, , Hong Kong
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New Territories, , Hong Kong
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Avellino, , Italy
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Aviano PN, , Italy
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Bari, , Italy
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Bologna, , Italy
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Brescia, , Italy
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Genova, , Italy
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Palermo, , Italy
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Pisa, , Italy
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Roma, , Italy
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Roma, , Italy
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Torino, , Italy
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Nagoya, Aichi-ken, Japan
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Kashiwa, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Kure, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Morioka, Iwate, Japan
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Kitaadachi-gun, Saitama, Japan
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Suntou-gun, Shizuoka, Japan
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Yonago, Tottori, Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Deventer, , Netherlands
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Leiden, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Chelyabinsk, , Russia
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Ivanovo, , Russia
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Krasnodar, , Russia
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Moscow, , Russia
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Obninsk, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Ufa, , Russia
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Voronezh, , Russia
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Goyang-si, Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Zaragoza, Aragon, Spain
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Palma de Mallorca, Balearic Islands, Spain
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Badalona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Girona, Catalonia, Spain
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Lleida, Catalonia, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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El Palmar, Murcia, Spain
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Oviedo, Principality of Asturias, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
Countries
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References
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Fujiwara K, Monk BJ, Lhomme C, Coleman RL, Brize A, Oaknin A, Ray-Coquard I, Fabbro M, Provencher D, Bamias A, Vergote I, DeCensi A, Zhang K, Vogl FD, Bach BA, Raspagliesi F. Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Ann Oncol. 2016 Jun;27(6):1006-1013. doi: 10.1093/annonc/mdw147. Epub 2016 Mar 30.
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Vergote I, Scambia G, O'Malley DM, Van Calster B, Park SY, Del Campo JM, Meier W, Bamias A, Colombo N, Wenham RM, Covens A, Marth C, Raza Mirza M, Kroep JR, Ma H, Pickett CA, Monk BJ; TRINOVA-3/ENGOT-ov2/GOG-3001 investigators. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):862-876. doi: 10.1016/S1470-2045(19)30178-0. Epub 2019 May 7.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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TRINOVA-3 20101129/ENGOT-ov2
Identifier Type: -
Identifier Source: secondary_id
20101129
Identifier Type: -
Identifier Source: org_study_id
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