Fallopian Tube CancerPhase 3NCT01493505

TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

A Phase 3 study testing AMG 386, Paclitaxel and Carboplatin in people with Fallopian Tube Cancer and Ovarian Cancer, run by Amgen at 310 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
What is being tested?: AMG 386, Paclitaxel and Carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,015 participants
Where: 310 sitesin 14 countries
Study dates: Jan 2012to Dec 2016
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

310 sites in 14 countries.

Country

City, postcode or hospital

310 sites in 14 countries

United States173 sites

Research Site
Abington, Pennsylvania, 19001
Research Site
Akron, Ohio, 44304
Research Site
Albany, New York, 12208
Research Site
Albuquerque, New Mexico, 87102
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Albuquerque, New Mexico, 87131
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Ames, Iowa, 50010
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Anchorage, Alaska, 99508
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Annandale, Virginia, 22003
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Asheville, North Carolina, 28806
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Augusta, Georgia, 30912
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Aurora, Colorado, 80045
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Austin, Texas, 78701
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Austin, Texas, 78731
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Baltimore, Maryland, 21204
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Baltimore, Maryland, 21215
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Baltimore, Maryland, 21237
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Bedford, Texas, 76022
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Bend, Oregon, 97701
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Berkeley, California, 94704
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Bethlehem, Pennsylvania, 18015
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Billings, Montana, 59101
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Birmingham, Alabama, 35233
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Boston, Massachusetts, 02114
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Bridgeport, Connecticut, 06606
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Brightwaters, New York, 11718
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Buffalo, New York, 14263
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Burbank, California, 91505
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Burlington, Massachusetts, 01805
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Burlington, North Carolina, 27215
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Burlington, Vermont, 05401
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Canton, Ohio, 44710
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Chapel Hill, North Carolina, 27599-7570
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28204
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Charlottesville, Virginia, 22908
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Chattanooga, Tennessee, 37403
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Chicago, Illinois, 60611
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Chicago, Illinois, 60612
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Chicago, Illinois, 60637
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Cincinnati, Ohio, 45220
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Cincinnati, Ohio, 45267-0457
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44106
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Cleveland, Ohio, 44109
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Cleveland, Ohio, 44195
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Columbia, South Carolina, 29210
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Columbus, Ohio, 43210
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Columbus, Ohio, 43214
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Concord, California, 94520
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Concord, North Carolina, 28025
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Corona, California, 92879
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Covington, Louisiana, 70433
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Dallas, Texas, 75231
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Dallas, Texas, 75246
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Dallas, Texas, 75390-9032
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Danvers, Massachusetts, 01923
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Decatur, Illinois, 62526
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Detroit, Michigan, 48201
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Detroit, Michigan, 48202
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Durham, North Carolina, 27710
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Edgewood, Kentucky, 41017
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Englewood, Colorado, 80113
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Evanston, Illinois, 60201
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Fargo, North Dakota, 58122
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Farmington, Connecticut, 06030
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Gainesville, Georgia, 30501
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Galveston, Texas, 77555
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Gilbert, Arizona, 85234
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Green Bay, Wisconsin, 54301
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Green Bay, Wisconsin, 54311
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Greenville, South Carolina, 29601
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Greenville, South Carolina, 29605
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Hackensack, New Jersey, 07601
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Hartford, Connecticut, 06106
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Hinsdale, Illinois, 60521
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Hollywood, Florida, 33021
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Honolulu, Hawaii, 96826
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Houston, Texas, 77030
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Indianapolis, Indiana, 46202
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Indianapolis, Indiana, 46237
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Indianapolis, Indiana, 46260
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Iowa City, Iowa, 52242
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Jackson, Mississippi, 39216
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Jamaica, New York, 11432
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Joliet, Illinois, 60435
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Kalamazoo, Michigan, 49007
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Kansas City, Kansas, 66160
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Kansas City, Missouri, 64111
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Kettering, Ohio, 45429
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La Jolla, California, 92093-0957
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Lafayette, Louisiana, 70503
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Lake Success, New York, 11042
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Las Vegas, Nevada, 89169
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Lebanon, New Hampshire, 03756
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Lexington, Kentucky, 40536
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Lincoln, Nebraska, 68506
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Long Beach, California, 90806
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Los Angeles, California, 90027
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Macon, Georgia, 31201
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Marshfield, Wisconsin, 54449
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Mayfield Heights, Ohio, 44124
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Maywood, Illinois, 60153
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Miami, Florida, 33146
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Milwaukee, Wisconsin, 53215
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Milwaukee, Wisconsin, 53226
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Milwaukee, Wisconsin, 53233
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Minneapolis, Minnesota, 55416
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Mobile, Alabama, 36604
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Munster, Indiana, 46321
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Neptune City, New Jersey, 07753
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New Britain, Connecticut, 06050
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New York, New York, 10029
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New York, New York, 10032
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New York, New York, 10065
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Norfolk, Virginia, 23502
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Oak Lawn, Illinois, 60453
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Ogden, Utah, 84403
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Oklahoma City, Oklahoma, 73104
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Orange, California, 92868
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Orlando, Florida, 32804
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Orlando, Florida, 32806
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Oshkosh, Wisconsin, 54904
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Oxnard, California, 93030
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Park Ridge, Illinois, 60068
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Peoria, Arizona, 85381
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Philadelphia, Pennsylvania, 19104
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Philadelphia, Pennsylvania, 19107
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Phoenix, Arizona, 85013
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Phoenix, Arizona, 85016
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Pittsburgh, Pennsylvania, 15213
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Pittsburgh, Pennsylvania, 15224
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Providence, Rhode Island, 02905
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Radnor, Pennsylvania, 19087
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Rancho Mirage, California, 92270
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Reno, Nevada, 89502
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Roanoke, Virginia, 24016
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Rochester, Minnesota, 55905
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Sacramento, California, 95816
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Sacramento, California, 95817
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Saint Louis Park, Minnesota, 55426
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San Antonio, Texas, 78217
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San Diego, California, 92123
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Savannah, Georgia, 31404
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Scarborough, Maine, 04074
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Seattle, Washington, 98104
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Sheboygan, Wisconsin, 53081
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Sioux Falls, South Dakota, 57105
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South Bend, Indiana, 46628
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St Louis, Missouri, 63110
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St. Petersburg, Florida, 33701
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Stamford, Connecticut, 06902
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Syracuse, New York, 13210
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Tacoma, Washington, 98405
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Tampa, Florida, 33612
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The Bronx, New York, 10461
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The Woodlands, Texas, 77380
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Toledo, Ohio, 43614
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Tucson, Arizona, 85710
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Tucson, Arizona, 85724-5024
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Tulsa, Oklahoma, 74136
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Urbana, Illinois, 61801
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Voorhees Township, New Jersey, 08043
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Waukesha, Wisconsin, 53188
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Wausau, Wisconsin, 54401
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Wenatchee, Washington, 98801
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West Allis, Wisconsin, 53227
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West Reading, Pennsylvania, 19611
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Wilmington, North Carolina, 28402
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Winchester, Virginia, 22601
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Winston-Salem, North Carolina, 27103
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Winston-Salem, North Carolina, 27157
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Woodbridge, Virginia, 22191
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Worcester, Massachusetts, 01605

Other trials in United States

Germany26 sites

Research Site
Berlin, 13353
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Dresden, 01307
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Düsseldorf, 40217
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Düsseldorf, 40225
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Erlangen, 91054
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Essen, 45136
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Essen, 45147
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Frankfurt am Main, 60590
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Frankfurt am Main, 65929
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Freiburg im Breisgau, 79106
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Hamburg, 20246
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Hanover, 30177
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Hanover, 30625
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Kiel, 24105
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Konstanz, 78464
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Leipzig, 04103
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Ludwigsburg, 71640
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München, 80337
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München, 81377
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München, 81675
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Oldenburg, 26121
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Ravensburg, 88212
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Rostock, 18059
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Stuttgart, 70374
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Tübingen, 72076
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Ulm, 89075

Other trials in Germany

Spain19 sites

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Badalona, Catalonia, 08916
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Barcelona, Catalonia, 08035
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El Palmar, Murcia, 30120
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Girona, Catalonia, 17007
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Lleida, Catalonia, 25198
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Madrid, Madrid, 28009
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Madrid, Madrid, 28033
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Madrid, Madrid, 28034
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Madrid, Madrid, 28040
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Madrid, Madrid, 28041
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Madrid, Madrid, 28046
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Madrid, Madrid, 28050
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Madrid, Madrid, 28922
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Oviedo, Principality of Asturias, 33006
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Palma de Mallorca, Balearic Islands, 07198
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Valencia, Valencia, 46009
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Valencia, Valencia, 46014
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Valencia, Valencia, 46026
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Zaragoza, Aragon, 50009

Other trials in Spain

Belgium18 sites

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Bonheiden, 2820
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Brasschaat, 2930
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Brussels, 1000
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Charleroi, 6000
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Duffel, 2570
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Edegem, 2650
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Ghent, 9000
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Hasselt, 3500
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Kortrijk, 8500
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Leuven, 3000
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Libramont, 6800
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Liège, 4000
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Namur, 5000
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Ostend, 8400
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Sint-Niklaas, 9100
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Turnhout, 2300
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Wilrijk, 2610
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Yvoir, 5530

Other trials in Belgium

Italy15 sites

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Avellino, 83100
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Aviano PN, 33081
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Bari, 70124
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Bologna, 40138
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Brescia, 25123
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Genova, 16132
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Milan, 20133
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Milan, 20141
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Naples, 80131
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Novara, 28100
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Palermo, 90126
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Pisa, 56126
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Roma, 00144
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Roma, 00168
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Torino, 10126

Other trials in Italy

Japan12 sites

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Fukuoka, Fukuoka, 811-1395
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Kashiwa, Chiba, 277-8567
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Kitaadachi-gun, Saitama, 362-0806
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Kure, Hiroshima, 737-0023
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Kurume, Fukuoka, 830-0011
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Morioka, Iwate, 020-8505
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Nagoya, Aichi-ken, 464-8681
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Sapporo, Hokkaido, 003-0804
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Suntou-gun, Shizuoka, 411-8777
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Tokyo, 105-8471
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Tokyo, 160-8582
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Yonago, Tottori, 683-8504

Other trials in Japan

Canada10 sites

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Calgary, Alberta, T2N 4N2
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Edmonton, Alberta, T6G 1Z2
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Halifax, Nova Scotia, B3H 1V7
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Kingston, Ontario, K7L 5P9
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London, Ontario, N6A 4L6
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Montreal, Quebec, H2L 4M1
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Québec, Quebec, G1R 2J6
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Sault Ste. Marie, Ontario, P6B 0A8
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Toronto, Ontario, M4N 3M5
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Toronto, Ontario, M5G 2M9

Other trials in Canada

Russia9 sites

Research Site
Chelyabinsk, 454087
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Ivanovo, 153013
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Krasnodar, 350040
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Moscow, 115478
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Obninsk, 249036
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Pyatigorsk, 357502
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Saint Petersburg, 197022
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Ufa, 450054
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Voronezh, 394000

Other trials in Russia

Austria7 sites

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Graz, 8020
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Graz, 8036
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Innsbruck, 6020
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Linz, 4010
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Linz, 4020
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Salzburg, 5020
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Vienna, 1130

Other trials in Austria

Greece7 sites

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Athens, 11522
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Athens, 11527
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Athens, 11528
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Athens, 14564
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Larissa, 41110
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Pátrai, 26500
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Thessaloniki, 56429

Other trials in Greece

Netherlands4 sites

Research Site
Deventer, 7416 SE
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Leiden, 2333 ZA
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Nijmegen, 6525 GA
Research Site
Rotterdam, 3015 CE

Other trials in Netherlands

South Korea4 sites

Research Site
Goyang-si, Gyeonggi-do, 410-769
Research Site
Seoul, 110-744
Research Site
Seoul, 135-710
Research Site
Seoul, 138-736

Other trials in South Korea

Denmark3 sites

Research Site
Herlev, 2730
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København Ø, 2100
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Roskilde, 4000

Other trials in Denmark

Hong Kong3 sites

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Hong Kong
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Kowloon
Research Site
New Territories

Other trials in Hong Kong

About this study

Official title: 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

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.

Conditions: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Being tested: AMG 386, Paclitaxel, AMG 386 Placebo, Carboplatin
Keywords: Primary Peritoneal Cancer
Medical subject headings: Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMG 386Drug
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
PaclitaxelDrug
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
AMG 386 PlaceboDrug
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
CarboplatinDrug
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)

Study groups in NCT01493505
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Paclitaxel Carboplatin Receives: Drug: Paclitaxel; Drug: AMG 386 Placebo; Drug: Carboplatin
AMG 386	Active comparator	AMG 386 Paclitaxel Carboplatin Receives: Drug: AMG 386; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression free survival
Measured: 3 years

Secondary outcomes (8)

Overall survival (OS)
Measured: 5 years
Incidence of adverse events and significant laboratory abnormalities
Measured: 4 years
Pharmacokinetics of AMG 386 (Cmax and Cmin)
pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7
Measured: 1 year
Incidence of anti-AMG 386 antibody formation
pre-dose weeks 1, 10, 19
Measured: 4 years
Patient reported ovarian cancer-specific symptoms and health related quality of life
Measured: 4 years
Patient reported status as measured by the EuroQOL (EQ-5D)
Measured: 4 years
AMG 386 exposure-response relationships for PFS and OS
Measured: 4 years
Correlation of serum biomarkers with measures of response
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Dec 2016

First posted16 Dec 2011 (estimated)
Study startJan 2012
Primary completionMar 2016
Study completionDec 2016

Why it stopped: Amgen Administrative Decision - termination of LTFU

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,015 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01493505
Sponsor's protocol ID: 20101129
Other IDs: TRINOVA-3 20101129/ENGOT-ov2
Status last verified: Feb 2017
First submitted: 29 Sep 2011
Last updated: 23 Feb 2017
Results posted: No

Publications

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.
PubMed 27029706
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.
PubMed 37185961
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.
PubMed 31076365

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fallopian Tube Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01493505
Acronym / sponsor ID: 20101129
Conditions: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Keywords: Primary Peritoneal Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Amgen Administrative Decision - termination of LTFU
Enrolment: 1,015 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Mar 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 16 Dec 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Paclitaxel, Drug: AMG 386 Placebo, Drug: CarboplatinPlacebo Paclitaxel Carboplatin
AMG 386	Active comparator	Drug: AMG 386, Drug: Paclitaxel, Drug: CarboplatinAMG 386 Paclitaxel Carboplatin

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMG 386AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)	Drug	AMG 386
PaclitaxelPaclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)	Drug	AMG 386, Placebo
AMG 386 PlaceboAMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)	Drug	Placebo
CarboplatinCarboplatin AUC 5 or 6 IV Q3W (6 cycles)	Drug	AMG 386, Placebo

Primary outcome

Progression free survival
Time frame: 3 years

8 secondary outcomes

Overall survival (OS)
Time frame: 5 years
Incidence of adverse events and significant laboratory abnormalities
Time frame: 4 years
Pharmacokinetics of AMG 386 (Cmax and Cmin)
Time frame: 1 year
Incidence of anti-AMG 386 antibody formation
Time frame: 4 years
Patient reported ovarian cancer-specific symptoms and health related quality of life
Time frame: 4 years
Patient reported status as measured by the EuroQOL (EQ-5D)
Time frame: 4 years
AMG 386 exposure-response relationships for PFS and OS
Time frame: 4 years
Correlation of serum biomarkers with measures of response
Time frame: 4 years

Results and safety

The study was stopped early (reason given: Amgen Administrative Decision - termination of LTFU). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Background: PubMed 27029706Fujiwara 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.
Derived from this study: PubMed 37185961Gaitskell 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.
Derived from this study: PubMed 31076365Vergote 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

310 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AMG 386, Paclitaxel and Carboplatin in people with Fallopian Tube Cancer and Ovarian Cancer, run by Amgen at 310 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 310 sites in United States, Germany, Spain, Belgium, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Amgen Administrative Decision - termination of LTFU). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01493505, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.