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

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 Overview

• Status: Terminated
• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
• Intervention / Treatment: Drug: Paclitaxel; Drug: AMG 386 Placebo; Drug: Carboplatin; Drug: AMG 386

• Study Type: Interventional
• Enrollment (Actual): 1015
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Paclitaxel Carboplatin	Drug: Paclitaxel; Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles); Drug: AMG 386 Placebo; AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops); Drug: Carboplatin; Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Active Comparator: AMG 386; AMG 386 Paclitaxel Carboplatin	Drug: Paclitaxel; Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles); Drug: Carboplatin; Carboplatin AUC 5 or 6 IV Q3W (6 cycles); Drug: AMG 386; AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)		5 years
Incidence of adverse events and significant laboratory abnormalities		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	1 year
Incidence of anti-AMG 386 antibody formation	pre-dose weeks 1, 10, 19	4 years
Patient reported ovarian cancer-specific symptoms and health related quality of life		4 years
Patient reported status as measured by the EuroQOL (EQ-5D)		4 years
AMG 386 exposure-response relationships for PFS and OS		4 years
Correlation of serum biomarkers with measures of response		4 years

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General 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.
• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Primary Peritoneal Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Paclitaxel; Trebananib
• Other Study ID Numbers: 20101129; TRINOVA-3 20101129/ENGOT-ov2