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

22. februar 2017 opdateret af: Amgen

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1015

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Bonheiden, Belgien, 2820
        • Research Site
      • Brasschaat, Belgien, 2930
        • Research Site
      • Bruxelles, Belgien, 1000
        • Research Site
      • Charleroi, Belgien, 6000
        • Research Site
      • Duffel, Belgien, 2570
        • Research Site
      • Edegem, Belgien, 2650
        • Research Site
      • Gent, Belgien, 9000
        • Research Site
      • Hasselt, Belgien, 3500
        • Research Site
      • Kortrijk, Belgien, 8500
        • Research Site
      • Leuven, Belgien, 3000
        • Research Site
      • Libramont, Belgien, 6800
        • Research Site
      • Liège, Belgien, 4000
        • Research Site
      • Namur, Belgien, 5000
        • Research Site
      • Oostende, Belgien, 8400
        • Research Site
      • Sint-Niklaas, Belgien, 9100
        • Research Site
      • Turnhout, Belgien, 2300
        • Research Site
      • Wilrijk, Belgien, 2610
        • Research Site
      • Yvoir, Belgien, 5530
        • Research Site
  • Canada
      • Quebec, Canada, G1R 2J6
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Research Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Research Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • Research Site
      • London, Ontario, Canada, N6A 4L6
        • Research Site
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Research Site
  • Danmark
      • Herlev, Danmark, 2730
        • Research Site
      • København Ø, Danmark, 2100
        • Research Site
      • Roskilde, Danmark, 4000
        • Research Site
  • Den Russiske Føderation
      • Chelyabinsk, Den Russiske Føderation, 454087
        • Research Site
      • Ivanovo, Den Russiske Føderation, 153013
        • Research Site
      • Krasnodar, Den Russiske Føderation, 350040
        • Research Site
      • Moscow, Den Russiske Føderation, 115478
        • Research Site
      • Obninsk, Den Russiske Føderation, 249036
        • Research Site
      • Pyatigorsk, Den Russiske Føderation, 357502
        • Research Site
      • Saint Petersburg, Den Russiske Føderation, 197022
        • Research Site
      • Ufa, Den Russiske Føderation, 450054
        • Research Site
      • Voronezh, Den Russiske Føderation, 394000
        • Research Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Research Site
      • Mobile, Alabama, Forenede Stater, 36604
        • Research Site
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Research Site
    • Arizona
      • Gilbert, Arizona, Forenede Stater, 85234
        • Research Site
      • Peoria, Arizona, Forenede Stater, 85381
        • Research Site
      • Phoenix, Arizona, Forenede Stater, 85013
        • Research Site
      • Phoenix, Arizona, Forenede Stater, 85016
        • Research Site
      • Tucson, Arizona, Forenede Stater, 85710
        • Research Site
      • Tucson, Arizona, Forenede Stater, 85724-5024
        • Research Site
    • California
      • Berkeley, California, Forenede Stater, 94704
        • Research Site
      • Burbank, California, Forenede Stater, 91505
        • Research Site
      • Concord, California, Forenede Stater, 94520
        • Research Site
      • Corona, California, Forenede Stater, 92879
        • Research Site
      • La Jolla, California, Forenede Stater, 92093-0957
        • Research Site
      • Long Beach, California, Forenede Stater, 90806
        • Research Site
      • Los Angeles, California, Forenede Stater, 90027
        • Research Site
      • Orange, California, Forenede Stater, 92868
        • Research Site
      • Oxnard, California, Forenede Stater, 93030
        • Research Site
      • Rancho Mirage, California, Forenede Stater, 92270
        • Research Site
      • Sacramento, California, Forenede Stater, 95817
        • Research Site
      • Sacramento, California, Forenede Stater, 95816
        • Research Site
      • San Diego, California, Forenede Stater, 92123
        • Research Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Research Site
      • Englewood, Colorado, Forenede Stater, 80113
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater, 06606
        • Research Site
      • Farmington, Connecticut, Forenede Stater, 06030
        • Research Site
      • Hartford, Connecticut, Forenede Stater, 06106
        • Research Site
      • New Britain, Connecticut, Forenede Stater, 06050
        • Research Site
      • Stamford, Connecticut, Forenede Stater, 06902
        • Research Site
    • Florida
      • Clearwater, Florida, Forenede Stater, 33756
        • Research Site
      • Hollywood, Florida, Forenede Stater, 33021
        • Research Site
      • Miami, Florida, Forenede Stater, 33146
        • Research Site
      • Orlando, Florida, Forenede Stater, 32804
        • Research Site
      • Orlando, Florida, Forenede Stater, 32806
        • Research Site
      • St Petersburg, Florida, Forenede Stater, 33701
        • Research Site
      • Tampa, Florida, Forenede Stater, 33612
        • Research Site
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Research Site
      • Gainesville, Georgia, Forenede Stater, 30501
        • Research Site
      • Macon, Georgia, Forenede Stater, 31201
        • Research Site
      • Savannah, Georgia, Forenede Stater, 31404
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96826
        • Research Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Research Site
      • Chicago, Illinois, Forenede Stater, 60637
        • Research Site
      • Chicago, Illinois, Forenede Stater, 60611
        • Research Site
      • Decatur, Illinois, Forenede Stater, 62526
        • Research Site
      • Evanston, Illinois, Forenede Stater, 60201
        • Research Site
      • Hinsdale, Illinois, Forenede Stater, 60521
        • Research Site
      • Joliet, Illinois, Forenede Stater, 60435
        • Research Site
      • Maywood, Illinois, Forenede Stater, 60153
        • Research Site
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Research Site
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Research Site
      • Urbana, Illinois, Forenede Stater, 61801
        • Research Site
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46237
        • Research Site
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Research Site
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Research Site
      • Munster, Indiana, Forenede Stater, 46321
        • Research Site
      • South Bend, Indiana, Forenede Stater, 46628
        • Research Site
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • Research Site
      • Iowa City, Iowa, Forenede Stater, 52242
        • Research Site
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Research Site
    • Kentucky
      • Edgewood, Kentucky, Forenede Stater, 41017
        • Research Site
      • Lexington, Kentucky, Forenede Stater, 40536
        • Research Site
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
        • Research Site
      • Lafayette, Louisiana, Forenede Stater, 70503
        • Research Site
    • Maine
      • Scarborough, Maine, Forenede Stater, 04074
        • Research Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21204
        • Research Site
      • Baltimore, Maryland, Forenede Stater, 21237
        • Research Site
      • Baltimore, Maryland, Forenede Stater, 21215
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Research Site
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Research Site
      • Danvers, Massachusetts, Forenede Stater, 01923
        • Research Site
      • Worcester, Massachusetts, Forenede Stater, 01605
        • Research Site
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Research Site
      • Detroit, Michigan, Forenede Stater, 48201
        • Research Site
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55416
        • Research Site
      • Rochester, Minnesota, Forenede Stater, 55905
        • Research Site
      • St. Louis Park, Minnesota, Forenede Stater, 55426
        • Research Site
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • Research Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Research Site
      • St Louis, Missouri, Forenede Stater, 63110
        • Research Site
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68506
        • Research Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Research Site
      • Reno, Nevada, Forenede Stater, 89502
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Research Site
      • Neptune, New Jersey, Forenede Stater, 07753
        • Research Site
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • Research Site
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • Research Site
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Research Site
      • Brightwaters, New York, Forenede Stater, 11718
        • Research Site
      • Bronx, New York, Forenede Stater, 10461
        • Research Site
      • Buffalo, New York, Forenede Stater, 14263
        • Research Site
      • Jamaica, New York, Forenede Stater, 11432
        • Research Site
      • Lake Success, New York, Forenede Stater, 11042
        • Research Site
      • New York, New York, Forenede Stater, 10032
        • Research Site
      • New York, New York, Forenede Stater, 10065
        • Research Site
      • New York, New York, Forenede Stater, 10029
        • Research Site
      • Syracuse, New York, Forenede Stater, 13210
        • Research Site
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28806
        • Research Site
      • Burlington, North Carolina, Forenede Stater, 27215
        • Research Site
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7570
        • Research Site
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Research Site
      • Concord, North Carolina, Forenede Stater, 28025
        • Research Site
      • Durham, North Carolina, Forenede Stater, 27710
        • Research Site
      • Wilmington, North Carolina, Forenede Stater, 28402
        • Research Site
      • Winston Salem, North Carolina, Forenede Stater, 27103
        • Research Site
      • Winston Salem, North Carolina, Forenede Stater, 27157
        • Research Site
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • Research Site
    • Ohio
      • Akron, Ohio, Forenede Stater, 44304
        • Research Site
      • Canton, Ohio, Forenede Stater, 44710
        • Research Site
      • Cincinnati, Ohio, Forenede Stater, 45220
        • Research Site
      • Cincinnati, Ohio, Forenede Stater, 45267-0457
        • Research Site
      • Cleveland, Ohio, Forenede Stater, 44195
        • Research Site
      • Cleveland, Ohio, Forenede Stater, 44109
        • Research Site
      • Cleveland, Ohio, Forenede Stater, 44106
        • Research Site
      • Columbus, Ohio, Forenede Stater, 43210
        • Research Site
      • Columbus, Ohio, Forenede Stater, 43214
        • Research Site
      • Kettering, Ohio, Forenede Stater, 45429
        • Research Site
      • Mayfield Heights, Ohio, Forenede Stater, 44124
        • Research Site
      • Toledo, Ohio, Forenede Stater, 43614
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Research Site
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Research Site
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Research Site
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • Research Site
      • Bethlehem, Pennsylvania, Forenede Stater, 18015
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Research Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Research Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Research Site
      • Radnor, Pennsylvania, Forenede Stater, 19087
        • Research Site
      • West Reading, Pennsylvania, Forenede Stater, 19611
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02905
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Research Site
      • Columbia, South Carolina, Forenede Stater, 29210
        • Research Site
      • Greenville, South Carolina, Forenede Stater, 29605
        • Research Site
      • Greenville, South Carolina, Forenede Stater, 29601
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • Research Site
    • Texas
      • Austin, Texas, Forenede Stater, 78731
        • Research Site
      • Austin, Texas, Forenede Stater, 78701
        • Research Site
      • Bedford, Texas, Forenede Stater, 76022
        • Research Site
      • Dallas, Texas, Forenede Stater, 75246
        • Research Site
      • Dallas, Texas, Forenede Stater, 75231
        • Research Site
      • Dallas, Texas, Forenede Stater, 75390-9032
        • Research Site
      • Galveston, Texas, Forenede Stater, 77555
        • Research Site
      • Houston, Texas, Forenede Stater, 77030
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78217
        • Research Site
      • The Woodlands, Texas, Forenede Stater, 77380
        • Research Site
    • Utah
      • Ogden, Utah, Forenede Stater, 84403
        • Research Site
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Research Site
    • Virginia
      • Annandale, Virginia, Forenede Stater, 22003
        • Research Site
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Research Site
      • Norfolk, Virginia, Forenede Stater, 23502
        • Research Site
      • Roanoke, Virginia, Forenede Stater, 24016
        • Research Site
      • Winchester, Virginia, Forenede Stater, 22601
        • Research Site
      • Woodbridge, Virginia, Forenede Stater, 22191
        • Research Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Research Site
      • Tacoma, Washington, Forenede Stater, 98405
        • Research Site
      • Wenatchee, Washington, Forenede Stater, 98801
        • Research Site
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Research Site
      • Green Bay, Wisconsin, Forenede Stater, 54311
        • Research Site
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Research Site
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Research Site
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Research Site
      • Milwaukee, Wisconsin, Forenede Stater, 53233
        • Research Site
      • Oshkosh, Wisconsin, Forenede Stater, 54904
        • Research Site
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • Research Site
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Research Site
      • Wausau, Wisconsin, Forenede Stater, 54401
        • Research Site
      • West Allis, Wisconsin, Forenede Stater, 53227
        • Research Site
  • Grækenland
      • Athens, Grækenland, 11527
        • Research Site
      • Athens, Grækenland, 11528
        • Research Site
      • Athens, Grækenland, 11522
        • Research Site
      • Athens, Grækenland, 14564
        • Research Site
      • Larissa, Grækenland, 41110
        • Research Site
      • Patra, Grækenland, 26500
        • Research Site
      • Thessaloniki, Grækenland, 56429
        • Research Site
  • Holland
      • Deventer, Holland, 7416 SE
        • Research Site
      • Leiden, Holland, 2333 ZA
        • Research Site
      • Nijmegen, Holland, 6525 GA
        • Research Site
      • Rotterdam, Holland, 3015 CE
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • Kowloon, Hong Kong
        • Research Site
      • New Territories, Hong Kong
        • Research Site
  • Italien
      • Avellino, Italien, 83100
        • Research Site
      • Aviano PN, Italien, 33081
        • Research Site
      • Bari, Italien, 70124
        • Research Site
      • Bologna, Italien, 40138
        • Research Site
      • Brescia, Italien, 25123
        • Research Site
      • Genova, Italien, 16132
        • Research Site
      • Milano, Italien, 20141
        • Research Site
      • Milano, Italien, 20133
        • Research Site
      • Napoli, Italien, 80131
        • Research Site
      • Novara, Italien, 28100
        • Research Site
      • Palermo, Italien, 90126
        • Research Site
      • Pisa, Italien, 56126
        • Research Site
      • Roma, Italien, 00168
        • Research Site
      • Roma, Italien, 00144
        • Research Site
      • Torino, Italien, 10126
        • Research Site
  • Japan
      • Tokyo, Japan, 105-8471
        • Research Site
      • Tokyo, Japan, 160-8582
        • Research Site
    • Aichi
      • Nagoya-city, Aichi, Japan, 464-8681
        • Research Site
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8567
        • Research Site
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 811-1395
        • Research Site
      • Kurume-city, Fukuoka, Japan, 830-0011
        • Research Site
    • Hiroshima
      • Kure-city, Hiroshima, Japan, 737-0023
        • Research Site
    • Hokkaido
      • Sapporo-city, Hokkaido, Japan, 003-0804
        • Research Site
    • Iwate
      • Morioka-city, Iwate, Japan, 020-8505
        • Research Site
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Research Site
    • Shizuoka
      • Suntou-gun, Shizuoka, Japan, 411-8777
        • Research Site
    • Tottori
      • Yonago-city, Tottori, Japan, 683-8504
        • Research Site
  • Korea, Republikken
      • Goyang-si, Gyeonggi-do, Korea, Republikken, 410-769
        • Research Site
      • Seoul, Korea, Republikken, 135-710
        • Research Site
      • Seoul, Korea, Republikken, 138-736
        • Research Site
      • Seoul, Korea, Republikken, 110-744
        • Research Site
  • Spanien
      • Madrid, Spanien, 28034
        • Research Site
      • Madrid, Spanien, 28046
        • Research Site
      • Madrid, Spanien, 28041
        • Research Site
      • Madrid, Spanien, 28040
        • Research Site
      • Madrid, Spanien, 28009
        • Research Site
      • Madrid, Spanien, 28050
        • Research Site
      • Madrid, Spanien, 28033
        • Research Site
      • Madrid, Spanien, 28922
        • Research Site
    • Aragón
      • Zaragoza, Aragón, Spanien, 50009
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spanien, 33006
        • Research Site
    • Baleares
      • Palma de Mallorca, Baleares, Spanien, 07198
        • Research Site
    • Cataluña
      • Badalona, Cataluña, Spanien, 08916
        • Research Site
      • Barcelona, Cataluña, Spanien, 08035
        • Research Site
      • Girona, Cataluña, Spanien, 17007
        • Research Site
      • Lleida, Cataluña, Spanien, 25198
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spanien, 46009
        • Research Site
      • Valencia, Comunidad Valenciana, Spanien, 46014
        • Research Site
      • Valencia, Comunidad Valenciana, Spanien, 46026
        • Research Site
    • Murcia
      • El Palmar, Murcia, Spanien, 30120
        • Research Site
  • Tyskland
      • Berlin, Tyskland, 13353
        • Research Site
      • Dresden, Tyskland, 01307
        • Research Site
      • Düsseldorf, Tyskland, 40225
        • Research Site
      • Düsseldorf, Tyskland, 40217
        • Research Site
      • Erlangen, Tyskland, 91054
        • Research Site
      • Essen, Tyskland, 45136
        • Research Site
      • Essen, Tyskland, 45147
        • Research Site
      • Frankfurt am Main, Tyskland, 65929
        • Research Site
      • Frankfurt am Main, Tyskland, 60590
        • Research Site
      • Freiburg, Tyskland, 79106
        • Research Site
      • Hamburg, Tyskland, 20246
        • Research Site
      • Hannover, Tyskland, 30625
        • Research Site
      • Hannover, Tyskland, 30177
        • Research Site
      • Kiel, Tyskland, 24105
        • Research Site
      • Konstanz, Tyskland, 78464
        • Research Site
      • Leipzig, Tyskland, 04103
        • Research Site
      • Ludwigsburg, Tyskland, 71640
        • Research Site
      • München, Tyskland, 80337
        • Research Site
      • München, Tyskland, 81675
        • Research Site
      • München, Tyskland, 81377
        • Research Site
      • Oldenburg, Tyskland, 26121
        • Research Site
      • Ravensburg, Tyskland, 88212
        • Research Site
      • Rostock, Tyskland, 18059
        • Research Site
      • Stuttgart, Tyskland, 70374
        • Research Site
      • Tübingen, Tyskland, 72076
        • Research Site
      • Ulm, Tyskland, 89075
        • Research Site
  • Østrig
      • Graz, Østrig, 8036
        • Research Site
      • Graz, Østrig, 8020
        • Research Site
      • Innsbruck, Østrig, 6020
        • Research Site
      • Linz, Østrig, 4010
        • Research Site
      • Linz, Østrig, 4020
        • Research Site
      • Salzburg, Østrig, 5020
        • Research Site
      • Wien, Østrig, 1130
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Placebo Paclitaxel Carboplatin
Medicin: Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
Medicin: AMG 386 Placebo
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
Medicin: Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Aktiv komparator: AMG 386
AMG 386 Paclitaxel Carboplatin
Medicin: Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
Medicin: Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Medicin: AMG 386
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Progressionsfri overlevelse
Tidsramme: 3 år
3 år

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2012

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

29. september 2011

Først indsendt, der opfyldte QC-kriterier

15. december 2011

Først opslået (Skøn)

16. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20101129
  • TRINOVA-3 20101129/ENGOT-ov2

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner