Study Stopped
Amgen Administrative Decision - termination of LTFU
TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
2 other identifiers
interventional
1,015
14 countries
310
Brief Summary
The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2012
Longer than P75 for phase_3
310 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
December 16, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 23, 2017
February 1, 2017
4.2 years
September 29, 2011
February 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
3 years
Secondary Outcomes (8)
Overall survival (OS)
5 years
Incidence of adverse events and significant laboratory abnormalities
4 years
Pharmacokinetics of AMG 386 (Cmax and Cmin)
1 year
Incidence of anti-AMG 386 antibody formation
4 years
Patient reported ovarian cancer-specific symptoms and health related quality of life
4 years
- +3 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo Paclitaxel Carboplatin
AMG 386
ACTIVE COMPARATORAMG 386 Paclitaxel Carboplatin
Interventions
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
Eligibility Criteria
You may qualify if:
- Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
- 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
You may not qualify if:
- Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (310)
Research Site
Birmingham, Alabama, 35233, United States
Research Site
Mobile, Alabama, 36604, United States
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Anchorage, Alaska, 99508, United States
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Gilbert, Arizona, 85234, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85013, United States
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Phoenix, Arizona, 85016, United States
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Tucson, Arizona, 85710, United States
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Tucson, Arizona, 85724-5024, United States
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Berkeley, California, 94704, United States
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Burbank, California, 91505, United States
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Concord, California, 94520, United States
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Corona, California, 92879, United States
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La Jolla, California, 92093-0957, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90027, United States
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Orange, California, 92868, United States
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Oxnard, California, 93030, United States
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Rancho Mirage, California, 92270, United States
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Sacramento, California, 95816, United States
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Sacramento, California, 95817, United States
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San Diego, California, 92123, United States
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Aurora, Colorado, 80045, United States
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Englewood, Colorado, 80113, United States
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Bridgeport, Connecticut, 06606, United States
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Farmington, Connecticut, 06030, United States
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Hartford, Connecticut, 06106, United States
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New Britain, Connecticut, 06050, United States
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Stamford, Connecticut, 06902, United States
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Clearwater, Florida, 33756, United States
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Hollywood, Florida, 33021, United States
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Miami, Florida, 33146, United States
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Orlando, Florida, 32804, United States
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Orlando, Florida, 32806, United States
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St. Petersburg, Florida, 33701, United States
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Tampa, Florida, 33612, United States
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Augusta, Georgia, 30912, United States
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Gainesville, Georgia, 30501, United States
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Macon, Georgia, 31201, United States
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Savannah, Georgia, 31404, United States
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Honolulu, Hawaii, 96826, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Decatur, Illinois, 62526, United States
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Evanston, Illinois, 60201, United States
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Hinsdale, Illinois, 60521, United States
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Joliet, Illinois, 60435, United States
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Maywood, Illinois, 60153, United States
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Oak Lawn, Illinois, 60453, United States
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Park Ridge, Illinois, 60068, United States
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Urbana, Illinois, 61801, United States
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Indianapolis, Indiana, 46202, United States
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Indianapolis, Indiana, 46237, United States
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Indianapolis, Indiana, 46260, United States
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Munster, Indiana, 46321, United States
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South Bend, Indiana, 46628, United States
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Ames, Iowa, 50010, United States
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Iowa City, Iowa, 52242, United States
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Kansas City, Kansas, 66160, United States
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Edgewood, Kentucky, 41017, United States
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Lexington, Kentucky, 40536, United States
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Covington, Louisiana, 70433, United States
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Lafayette, Louisiana, 70503, United States
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Scarborough, Maine, 04074, United States
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Baltimore, Maryland, 21204, United States
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Baltimore, Maryland, 21215, United States
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Baltimore, Maryland, 21237, United States
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Boston, Massachusetts, 02114, United States
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Burlington, Massachusetts, 01805, United States
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Danvers, Massachusetts, 01923, United States
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Worcester, Massachusetts, 01605, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Kalamazoo, Michigan, 49007, United States
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Minneapolis, Minnesota, 55416, United States
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Rochester, Minnesota, 55905, United States
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Saint Louis Park, Minnesota, 55426, United States
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Jackson, Mississippi, 39216, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63110, United States
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Billings, Montana, 59101, United States
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Lincoln, Nebraska, 68506, United States
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Las Vegas, Nevada, 89169, United States
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Reno, Nevada, 89502, United States
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Lebanon, New Hampshire, 03756, United States
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Hackensack, New Jersey, 07601, United States
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Neptune City, New Jersey, 07753, United States
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Voorhees Township, New Jersey, 08043, United States
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Albuquerque, New Mexico, 87102, United States
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Albuquerque, New Mexico, 87131, United States
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Albany, New York, 12208, United States
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Brightwaters, New York, 11718, United States
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Buffalo, New York, 14263, United States
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Jamaica, New York, 11432, United States
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Lake Success, New York, 11042, United States
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New York, New York, 10029, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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Syracuse, New York, 13210, United States
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The Bronx, New York, 10461, United States
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Asheville, North Carolina, 28806, United States
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Burlington, North Carolina, 27215, United States
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Chapel Hill, North Carolina, 27599-7570, United States
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Charlotte, North Carolina, 28204, United States
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Concord, North Carolina, 28025, United States
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Durham, North Carolina, 27710, United States
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Wilmington, North Carolina, 28402, United States
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Winston-Salem, North Carolina, 27103, United States
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Winston-Salem, North Carolina, 27157, United States
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Fargo, North Dakota, 58122, United States
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Akron, Ohio, 44304, United States
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Canton, Ohio, 44710, United States
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Cincinnati, Ohio, 45220, United States
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Cincinnati, Ohio, 45267-0457, United States
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Cleveland, Ohio, 44106, United States
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Cleveland, Ohio, 44109, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Columbus, Ohio, 43214, United States
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Kettering, Ohio, 45429, United States
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Mayfield Heights, Ohio, 44124, United States
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Toledo, Ohio, 43614, United States
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Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74136, United States
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Bend, Oregon, 97701, United States
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Abington, Pennsylvania, 19001, United States
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Bethlehem, Pennsylvania, 18015, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Radnor, Pennsylvania, 19087, United States
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West Reading, Pennsylvania, 19611, United States
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Providence, Rhode Island, 02905, United States
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Charleston, South Carolina, 29425, United States
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Columbia, South Carolina, 29210, United States
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Greenville, South Carolina, 29601, United States
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Greenville, South Carolina, 29605, United States
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Sioux Falls, South Dakota, 57105, United States
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Chattanooga, Tennessee, 37403, United States
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Austin, Texas, 78701, United States
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Austin, Texas, 78731, United States
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Bedford, Texas, 76022, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75390-9032, United States
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Galveston, Texas, 77555, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78217, United States
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The Woodlands, Texas, 77380, United States
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Ogden, Utah, 84403, United States
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Burlington, Vermont, 05401, United States
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Annandale, Virginia, 22003, United States
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Charlottesville, Virginia, 22908, United States
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Norfolk, Virginia, 23502, United States
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Roanoke, Virginia, 24016, United States
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Winchester, Virginia, 22601, United States
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Woodbridge, Virginia, 22191, United States
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Seattle, Washington, 98104, United States
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Tacoma, Washington, 98405, United States
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Wenatchee, Washington, 98801, United States
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Green Bay, Wisconsin, 54301, United States
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Green Bay, Wisconsin, 54311, United States
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Marshfield, Wisconsin, 54449, United States
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Milwaukee, Wisconsin, 53215, United States
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Milwaukee, Wisconsin, 53226, United States
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Milwaukee, Wisconsin, 53233, United States
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Oshkosh, Wisconsin, 54904, United States
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Sheboygan, Wisconsin, 53081, United States
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Waukesha, Wisconsin, 53188, United States
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Wausau, Wisconsin, 54401, United States
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West Allis, Wisconsin, 53227, United States
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Graz, 8020, Austria
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4010, Austria
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Vienna, 1130, Austria
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Bonheiden, 2820, Belgium
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Brasschaat, 2930, Belgium
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Brussels, 1000, Belgium
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Charleroi, 6000, Belgium
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Duffel, 2570, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Libramont, 6800, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Ostend, 8400, Belgium
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Sint-Niklaas, 9100, Belgium
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Turnhout, 2300, Belgium
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Wilrijk, 2610, Belgium
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Yvoir, 5530, Belgium
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Kingston, Ontario, K7L 5P9, Canada
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London, Ontario, N6A 4L6, Canada
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Sault Ste. Marie, Ontario, P6B 0A8, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Québec, Quebec, G1R 2J6, Canada
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Herlev, 2730, Denmark
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København Ø, 2100, Denmark
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Roskilde, 4000, Denmark
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Berlin, 13353, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40217, Germany
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Düsseldorf, 40225, Germany
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Erlangen, 91054, Germany
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Essen, 45136, Germany
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Essen, 45147, Germany
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Frankfurt am Main, 60590, Germany
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Frankfurt am Main, 65929, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20246, Germany
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Hanover, 30177, Germany
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Hanover, 30625, Germany
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Kiel, 24105, Germany
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Konstanz, 78464, Germany
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Leipzig, 04103, Germany
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Ludwigsburg, 71640, Germany
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München, 80337, Germany
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München, 81377, Germany
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München, 81675, Germany
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Oldenburg, 26121, Germany
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Ravensburg, 88212, Germany
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Rostock, 18059, Germany
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Stuttgart, 70374, Germany
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Tübingen, 72076, Germany
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Ulm, 89075, Germany
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Athens, 11522, Greece
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Athens, 11527, Greece
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Athens, 11528, Greece
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Athens, 14564, Greece
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Larissa, 41110, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 56429, 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, 83100, Italy
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Aviano PN, 33081, Italy
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Bari, 70124, Italy
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Bologna, 40138, Italy
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Brescia, 25123, Italy
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Genova, 16132, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Napoli, 80131, Italy
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Novara, 28100, Italy
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Palermo, 90126, Italy
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Pisa, 56126, Italy
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Roma, 00144, Italy
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Roma, 00168, Italy
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Torino, 10126, Italy
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Nagoya, Aichi-ken, 464-8681, Japan
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Kashiwa, Chiba, 277-8567, Japan
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Fukuoka, Fukuoka, 811-1395, Japan
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Kurume, Fukuoka, 830-0011, Japan
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Kure, Hiroshima, 737-0023, Japan
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Sapporo, Hokkaido, 003-0804, Japan
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Morioka, Iwate, 020-8505, Japan
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Kitaadachi-gun, Saitama, 362-0806, Japan
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Suntou-gun, Shizuoka, 411-8777, Japan
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Yonago, Tottori, 683-8504, Japan
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Tokyo, 105-8471, Japan
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Tokyo, 160-8582, Japan
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Deventer, 7416 SE, Netherlands
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Leiden, 2333 ZA, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Rotterdam, 3015 CE, Netherlands
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Chelyabinsk, 454087, Russia
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Ivanovo, 153013, Russia
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Krasnodar, 350040, Russia
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Moscow, 115478, Russia
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Obninsk, 249036, Russia
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Pyatigorsk, 357502, Russia
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Saint Petersburg, 197022, Russia
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Ufa, 450054, Russia
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Voronezh, 394000, Russia
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Goyang-si, Gyeonggi-do, 410-769, South Korea
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Seoul, 110-744, South Korea
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Seoul, 135-710, South Korea
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Seoul, 138-736, South Korea
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Zaragoza, Aragon, 50009, Spain
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Palma de Mallorca, Balearic Islands, 07198, Spain
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Badalona, Catalonia, 08916, Spain
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Barcelona, Catalonia, 08035, Spain
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Girona, Catalonia, 17007, Spain
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Lleida, Catalonia, 25198, Spain
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Madrid, Madrid, 28009, Spain
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Madrid, Madrid, 28033, Spain
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Madrid, Madrid, 28034, Spain
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Madrid, Madrid, 28040, Spain
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Madrid, Madrid, 28041, Spain
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Madrid, Madrid, 28046, Spain
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Madrid, Madrid, 28050, Spain
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Madrid, Madrid, 28922, Spain
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El Palmar, Murcia, 30120, Spain
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Oviedo, Principality of Asturias, 33006, Spain
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Valencia, Valencia, 46009, Spain
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Valencia, Valencia, 46014, Spain
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Valencia, Valencia, 46026, Spain
Related Publications (3)
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.
PMID: 27029706BACKGROUNDGaitskell 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.
PMID: 37185961DERIVEDVergote 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.
PMID: 31076365DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2011
First Posted
December 16, 2011
Study Start
January 1, 2012
Primary Completion
March 1, 2016
Study Completion
December 1, 2016
Last Updated
February 23, 2017
Record last verified: 2017-02