Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Amgen Identifier:
First received: January 20, 2011
Last updated: August 24, 2015
Last verified: August 2015

To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.

Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cancer
Drug: AMG386 plus PLD
Drug: Placebo plus PLD
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications [ Time Frame: Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment: 223
Study Start Date: March 2011
Estimated Study Completion Date: November 2018
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo plus PLD
Arm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
Drug: Placebo plus PLD

Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug.

PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)

Experimental: AMG386 plus PLD
Arm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
Drug: AMG386 plus PLD
AMG 386 is a first in class investigational anti angiogenic drug that provides potent and selective inhibition of angiopoietins. AMG 386 is designed to inhibit angiogenesis by sequestering Ang1 and Ang2, thereby preventing their interaction with the Tie2 receptor. Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
  • Female 18 years of age or older at the time the written informed consent is obtained
  • Adequate organ and hematological function

Exclusion Criteria:

  • Subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
  • Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy
  • Subjects with primary platinum-refractory disease
  • Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
  • History of central nervous system metastasis
  • Major surgery within 28 days prior to randomization or still recovering from prior surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01281254

  Hide Study Locations
United States, California
Research Site
Los Angeles, California, United States, 90027
Research Site
San Francisco, California, United States, 94143
United States, Connecticut
Research Site
Norwalk, Connecticut, United States, 06856
Research Site
Stamford, Connecticut, United States, 06902
United States, Florida
Research Site
Orlando, Florida, United States, 32806
Research Site
Tampa, Florida, United States, 33612
United States, Illinois
Research Site
Evanston, Illinois, United States, 60201
United States, Minnesota
Research Site
St. Louis Park, Minnesota, United States, 55426
United States, New York
Research Site
New York, New York, United States, 10029
United States, North Carolina
Research Site
Asheville, North Carolina, United States, 28806
Research Site
Durham, North Carolina, United States, 27710
Research Site
Winston Salem, North Carolina, United States, 27103
United States, North Dakota
Research Site
Bismarck, North Dakota, United States, 58501
United States, Pennsylvania
Research Site
Abington, Pennsylvania, United States, 19001
United States, South Dakota
Research Site
Sioux Falls, South Dakota, United States, 57104
United States, Texas
Research Site
Fort Sam Houston, Texas, United States, 78234
Research Site
San Antonio, Texas, United States, 78229
United States, Virginia
Research Site
Annandale, Virginia, United States, 22003
United States, Wisconsin
Research Site
Green Bay, Wisconsin, United States, 54301
Research Site
Milwaukee, Wisconsin, United States, 53215
Research Site
West Allis, Wisconsin, United States, 53227
Australia, New South Wales
Research Site
New Lambton Heights, New South Wales, Australia, 2305
Research Site
Wahroonga, New South Wales, Australia, 2076
Australia, Queensland
Research Site
Auchenflower, Queensland, Australia, 4066
Research Site
Greenslopes, Queensland, Australia, 4120
Australia, Victoria
Research Site
East Bentleigh, Victoria, Australia, 3165
Research Site
Footscray, Victoria, Australia, 3011
Research Site
Malvern, Victoria, Australia, 3144
Research Site
Parkville, Victoria, Australia, 3052
Research Site
Graz, Austria, 8020
Research Site
Graz, Austria, 8036
Research Site
Innsbruck, Austria, 6020
Research Site
Linz, Austria, 4010
Research Site
Wien, Austria, 1090
Research Site
Wien, Austria, 1160
Research Site
Charleroi, Belgium, 6000
Research Site
Edegem, Belgium, 2650
Research Site
Gent, Belgium, 9000
Research Site
Ieper, Belgium, 8900
Research Site
Leuven, Belgium, 3000
Research Site
Libramont, Belgium, 6800
Research Site
Liège, Belgium, 4000
Research Site
Namur, Belgium, 5000
Canada, Ontario
Research Site
London, Ontario, Canada, N6A 4L6
Research Site
Toronto, Ontario, Canada, M4N 3M5
Research Site
Toronto, Ontario, Canada, M5G 2M9
Research Site
Herlev, Denmark, 2730
Research Site
København, Denmark, 2100
Research Site
Amiens, France, 80000
Research Site
Avignon cedex 9, France, 84918
Research Site
Lyon cedex 8, France, 69373
Research Site
Poitiers, France, 86021
Research Site
Saint Cloud, France, 92210
Research Site
Berlin, Germany, 13353
Research Site
Bonn, Germany, 53105
Research Site
Düsseldorf, Germany, 40217
Research Site
Erlangen, Germany, 91054
Research Site
Essen, Germany, 45136
Research Site
Frankfurt am Main, Germany, 60590
Research Site
Freiburg, Germany, 79106
Research Site
Hannover, Germany, 30177
Research Site
Marburg, Germany, 35043
Research Site
München, Germany, 81377
Research Site
München, Germany, 81675
Research Site
Rostock, Germany, 18059
Research Site
Tübingen, Germany, 72076
Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
New Territories, Hong Kong
Research Site
Budapest, Hungary, 1032
Research Site
Budapest, Hungary, 1062
Research Site
Debrecen, Hungary, 4032
Research Site
Miskolc, Hungary, 3526
Research Site
Szeged, Hungary, 6720
Research Site
Zalaegerszeg - Pozva, Hungary, 8900
Research Site
Campobasso, Italy, 86100
Research Site
Genova, Italy, 16128
Research Site
Milano, Italy, 20133
Research Site
Milano, Italy, 20141
Research Site
Napoli, Italy, 80131
Research Site
Roma, Italy, 00128
Research Site
Roma, Italy, 00161
Research Site
Roma, Italy, 00168
New Zealand
Research Site
Grafton, Auckland, New Zealand, 1023
Research Site
Tauranga, New Zealand, 3143
Research Site
Bialystok, Poland, 15-027
Research Site
Gdansk, Poland, 80-219
Research Site
Singapore, Singapore, 169610
Research Site
Singapore, Singapore, 229899
Research Site
Bratislava, Slovakia, 812 50
Research Site
Bratislava, Slovakia, 831 01
Research Site
Kosice, Slovakia, 041 91
Research Site
Presov, Slovakia, 080 01
Research Site
Aarau, Switzerland, 5001
Research Site
Chur, Switzerland, 7000
Research Site
Geneva 14, Switzerland, 1211
Research Site
Zurich, Switzerland, 8091
Research Site
Tainan, Taiwan, 70403
Research Site
Taipei, Taiwan, 10041
Research Site
Taipei, Taiwan, 10449
United Kingdom
Research Site
London, United Kingdom, NW1 2PG
Research Site
London, United Kingdom, SE1 9RT
Research Site
London, United Kingdom, SW3 6JJ
Research Site
Manchester, United Kingdom, M20 4BX
Research Site
Northwood, United Kingdom, HA6 2RN
Research Site
Nottingham, United Kingdom, NG5 1PB
Research Site
Poole, United Kingdom, BH15 2JB
Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen Identifier: NCT01281254     History of Changes
Other Study ID Numbers: 20060517  2009-017946-30  ENGOT-ov-6  TRINOVA-2  20060517 
Study First Received: January 20, 2011
Last Updated: August 24, 2015
Health Authority: Australia: Austin Health Human Research Ethics Committee
Australia: Bellberry Human Research Ethics Committee
Australia: Hunter New England Human Research Ethics Committee
Australia: Melbourne Health Office for Research
Austria: Bundesamt für Sicherheit im Gesundheitswesen
Austria: Central Ethics Committee
Austria: Leitethikkommission der Medizinischen Universität Wien
Belgium: AZ Sint-Lucas Ethisch Comité
Belgium: Centre Hospitalier de l'Ardenne comité d'éthique
Belgium: Centre Hospitalier Régional de La Citadelle comité d'éthique
Belgium: Clinique Sainte Elisabeth comité d'éthique
Belgium: Commissie Medische Ethiek van de Universitaire Ziekenhuizen KULeuven
Belgium: Federal Agency for Medicines and Health ProductsBelgium: AZ Sint-Lucas Ethisch Comite
Belgium: Grand Hôpital de Charleroi comité d'éthique
Belgium: Jan Yperman ziekenhuis Ethisch Comité
Belgium: UZ Antwerpen Ethisch Comité
Canada: Health Canada
Denmark: Central Ethics Committee
Denmark: Danish Medicines Agency
Denmark: De Videnskabsetiske Komitéer for Region Hovedstaden (Ethics Committee for the Capital Region of Denmark)
Denmark: Laegemiddelstyrelsen
Denmark: Sundhedsstyrelsen (Danish Health and Medicines Authority)
France: Agence nationale de sécurité du médicament et des produits de santé (ANSM)
France: Central Ethics Committee: Comité de protection des personnes (CPP) Sud Est IV
Germany: Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM)
Germany: Bundesoberbehorde, BOB
Germany: Lead Ethics Committee: Ethic committee of the Nordrhein state medical board
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Greece: National Ethics Committee
Greece: National Organization of Medicines
Hong Kong: Department of Health
Hungary: Central Ethics Committee
Hungary: National Institute of Pharmacy
Italy: Agenzia Italiana del Farmaco
Italy: COMITATO ETICO del Policlinico Universitario Agostino Gemelli
Italy: Local Ethics Committees
Italy: Ministry of Health
Italy: The Istituto Superiore di Sanità (ISS) within the Italian National Health Service. Its activities include research, control, training and consultation in the interest of public health protection. Responsible to approved the phase 1 studies.
Latvia: Zāļu Klīniskās izpētes ētikas komiteja (Ethics Committee for Clinical trials of Medicinal products)
Latvia: Zāļu Valsts Agentūra (State Agency of Medicines)
Malaysia: National Pharmaceutical Control Bureau
New Zealand: Ethics Committee
New Zealand: Medicines and Medical Devices Safety Authority
Poland: Komisja Bioetyczna przy Okręgowej Izbie Lekarskiej w Białymstoku (Bioethics Committee for Medical Association)
Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Health Science Authority
Slovakia: Ethics Committees
Slovakia: Public Health Authority of the Slovak Republic
Slovakia: State Institiute for Drug Control
Slovakia: Local Ethics Committees
Slovakia: Ministry of Health
Slovakia: Štátny ústav pre kontrolu lieciv
Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMyPS)
Spain: Comité Ético de Investigación Clínica Hospital Universitario La Paz
Spain: Comité Ético de Investigación Clínica Hospital Arnau de Vilanova
Spain: Comité Ético de Investigación Clínica Hospital Clínico Univ. de Valencia
Spain: Comité Ético de Investigación Clínica Hospital Ramón y Cajal (for H. Ramón y Cajal and MD Anderson International)
Spain: Comité Ético de Investigación Clínica Parc de Salut Mar (Reference Ethic Committee)
Spain: Comité Ético de Investigación Hospital Clínico Universitario Virgen de la Victoria
South Korea: Korea Food & Drug Administration
Switzerland: Commission centrale d'éthique - Hôpitaux Universitaires de Genève
Switzerland: Kantonale Ethikkommission Aargau/Solothurn
Switzerland: Kantonale Ethikkommission Bern (KEK)
Switzerland: Kantonale Ethikkommission Zürich (KEK)
Switzerland: Swissmedic
Taiwan: Taiwan Food and Drug Administration
United Kingdom: Main Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Quorum Institutional Review Board

Keywords provided by Amgen:
Fallopian tube cancer
Primary peritoneal cancer
Pegylated Liposomal Doxorubicin
Recurrent epithelial ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on December 06, 2016