TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 919
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • Research Site
  • Queensland
    • Greenslopes, Queensland, Australia, 4120
      • Research Site
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Research Site
    • Bentleigh East, Victoria, Australia, 3165
      • Research Site
    • Footscray, Victoria, Australia, 3011
      • Research Site
    • Malvern, Victoria, Australia, 3144
      • Research Site
    • Parkville, Victoria, Australia, 3052
      • Research Site
• Belgium
  • Edegem, Belgium, 2650
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Namur, Belgium, 5000
    • Research Site
• Brazil
  • Rio de Janeiro, Brazil, 20220-410
    • Research Site
  • São Paulo, Brazil, 01317-000
    • Research Site
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Research Site
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Research Site
  • Santa Catarina
    • ItajaÃ-, Santa Catarina, Brazil, 88301-220
      • Research Site
  • São Paulo
    • Ribeirao Preto, São Paulo, Brazil, 14025-270
      • Research Site
• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • Research Site
  • Plovdiv, Bulgaria, 4004
    • Research Site
  • Sofia, Bulgaria, 1233
    • Research Site
  • Stara Zagora, Bulgaria, 6003
    • Research Site
  • Varna, Bulgaria, 9000
    • Research Site
• Canada
  • Quebec, Canada, G1R 2J6
    • Research Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Research Site
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Research Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Research Site
• Chile
  • CautÃ-n
    • Temuco, CautÃ-n, Chile, 4810469
      • Research Site
  • ValparaÃ-so
    • Valparaiso, ValparaÃ-so, Chile, 2363058
      • Research Site
• Croatia
  • Zagreb, Croatia, 10000
    • Research Site
• Czech Republic
  • Brno, Czech Republic, 625 00
    • Research Site
  • Brno, Czech Republic, 656 53
    • Research Site
  • Praha 2, Czech Republic, 128 51
    • Research Site
  • Praha 5, Czech Republic, 150 06
    • Research Site
• Estonia
  • Tallinn, Estonia, 13419
    • Research Site
  • Tartu, Estonia, 51014
    • Research Site
• France
  • Amiens, France, 80000
    • Research Site
  • Angers, France, 49933
    • Research Site
  • Avignon Cedex 2, France, 84082
    • Research Site
  • Bayonne, France, 64100
    • Research Site
  • Besancon Cedex, France, 25030
    • Research Site
  • Bordeaux Cedex, France, 33076
    • Research Site
  • Bordeaux Cedex, France, 33030
    • Research Site
  • Brest Cedex 2, France, 29609
    • Research Site
  • Dijon, France, 21079
    • Research Site
  • Le Mans, France, 72000
    • Research Site
  • Lille Cedex, France, 59020
    • Research Site
  • Lyon, France, 69008
    • Research Site
  • Marseille, France, 13009
    • Research Site
  • Marseille Cedex 09, France, 13273
    • Research Site
  • Marseille cedex 05, France, 13385
    • Research Site
  • Montpellier Cedex 5, France, 34298
    • Research Site
  • Nancy, France, 54100
    • Research Site
  • Nantes Cedex 2, France, 44202
    • Research Site
  • Nice cedex 2, France, 06189
    • Research Site
  • Orléans cedex 2, France, 45067
    • Research Site
  • Paris cedex 15, France, 75908
    • Research Site
  • Périgueux cedex, France, 24004
    • Research Site
  • Reims Cedex, France, 51092
    • Research Site
  • Saint Grégoire cedex, France, 35768
    • Research Site
  • Saint Herblain, France, 44800
    • Research Site
  • Strasbourg, France, 67000
    • Research Site
  • Villejuif cedex, France, 94805
    • Research Site
• Greece
  • Athens, Greece, 11528
    • Research Site
  • Heraklion, Greece, 71110
    • 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
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 024
      • Research Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 012
      • Research Site
    • Nashik, Maharashtra, India, 422 004
      • Research Site
    • Pune, Maharashtra, India, 411 004
      • Research Site
    • Pune, Maharashtra, India, 411 001
      • Research Site
• Israel
  • Haifa, Israel, 31096
    • Research Site
  • Holon, Israel, 58100
    • Research Site
  • Kefar Sava, Israel, 44281
    • Research Site
  • Tel Hashomer, Israel, 52621
    • Research Site
  • Tel-Aviv, Israel, 64239
    • Research Site
• Italy
  • Benevento, Italy, 82100
    • Research Site
  • Catania, Italy, 95126
    • Research Site
  • Cosenza (CS), Italy, 87100
    • Research Site
  • Genova, Italy, 16121
    • Research Site
  • Milano, Italy, 20141
    • Research Site
  • Milano, Italy, 20133
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Padova, Italy, 35128
    • Research Site
  • Potenza, Italy, 85100
    • Research Site
  • Roma, Italy, 00168
    • Research Site
  • Roma, Italy, 00161
    • Research Site
• Japan
  • Kurume-city, Japan, 830-0011
    • Research Site
  • Tokyo, Japan, 135-8550
    • Research Site
  • Tokyo, Japan, 105-8471
    • Research Site
  • Tokyo, Japan, 160-8582
    • Research Site
  • Aichi
    • Nagoya-city, Aichi, Japan, 464-8681
      • Research Site
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 811-1395
      • Research Site
  • Hiroshima
    • Kure-city, Hiroshima, Japan, 737-0023
      • Research Site
  • Hokkaido
    • Sapporo-city, Hokkaido, Japan, 104-0045
      • Research Site
  • Ibaraki
    • Tsukuba-city, Ibaraki, Japan, 305-8576
      • Research Site
  • Iwate
    • Morioka-city, Iwate, Japan, 020-8505
      • Research Site
  • Niigata
    • Niigata-city, Niigata, Japan, 951-8520
      • Research Site
  • Osaka
    • Osakasayama-city, Osaka, Japan, 589-8511
      • Research Site
  • Saitama
    • Hidaka-Shi, Saitama, Japan, 350-1298
      • Research Site
  • Shizuoka
    • Suntou-gun, Shizuoka, Japan, 411-8777
      • Research Site
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • 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, 137-701
    • Research Site
• Latvia
  • Daugavpils, Latvia, 5417
    • Research Site
  • Riga, Latvia, 1079
    • Research Site
  • Riga, Latvia, 1002
    • Research Site
• Malaysia
  • Johor
    • Johor Bahru, Johor, Malaysia, 81100
      • Research Site
  • Kelantan
    • Kota Bahru, Kelantan, Malaysia, 16150
      • Research Site
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603
      • Research Site
• Mexico
  • Distrito Federal, Mexico, 04380
    • Research Site
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 06726
      • Research Site
    • Mexico City, Distrito Federal, Mexico, 14080
      • Research Site
  • San Luis PotosÃ-
    • San Luis Potosi, San Luis PotosÃ-, Mexico, 78200
      • Research Site
• Peru
  • Lima, Peru, 11
    • Research Site
  • Lima, Peru, 31
    • Research Site
• Poland
  • Bydgoszcz, Poland, 85-796
    • Research Site
  • Gdansk, Poland, 80-219
    • Research Site
  • Lodz, Poland, 94-029
    • Research Site
  • Lublin, Poland, 20-090
    • Research Site
  • Poznan, Poland, 60-535
    • Research Site
  • Warszawa, Poland, 02-781
    • Research Site
• Portugal
  • Coimbra, Portugal, 3000-075
    • Research Site
  • Guimaraes, Portugal, 4835-044
    • Research Site
  • Lisboa, Portugal, 1500-650
    • Research Site
  • Porto, Portugal, 4200-319
    • Research Site
  • Porto, Portugal, 4200-072
    • Research Site
  • Santa Maria da Feira, Portugal, 4520-211
    • Research Site
• Romania
  • Bucharest, Romania, 011172
    • Research Site
  • Bucharest, Romania, 022328
    • Research Site
  • Cluj Napoca, Romania, 400015
    • Research Site
  • Suceava, Romania, 720237
    • Research Site
  • Targu Mures, Romania, 540142
    • Research Site
• Russian Federation
  • 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
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Research Site
• South Africa
  • Observatory, South Africa, 7925
    • Research Site
  • Port Elizabeth, South Africa, 6045
    • Research Site
  • Pretoria, South Africa, 0002
    • Research Site
  • Gauteng
    • Groenkloof, Gauteng, South Africa, 0181
      • Research Site
    • Johannesburg, Gauteng, South Africa, 2199
      • Research Site
  • Western Cape
    • Kraaifontein, Western Cape, South Africa, 7570
      • Research Site
• Spain
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Madrid, Spain, 28009
    • Research Site
  • Madrid, Spain, 28033
    • Research Site
  • AndalucÃ-a
    • Córdoba, AndalucÃ-a, Spain, 14004
      • Research Site
    • Huelva, AndalucÃ-a, Spain, 21005
      • Research Site
    • Málaga, AndalucÃ-a, Spain, 29010
      • Research Site
    • Sevilla, AndalucÃ-a, Spain, 41013
      • Research Site
  • Baleares
    • Palma de Mallorca, Baleares, Spain, 07198
      • Research Site
  • Castilla León
    • Salamanca, Castilla León, Spain, 37007
      • Research Site
  • Cataluña
    • Badalona, Cataluña, Spain, 08916
      • Research Site
    • Barcelona, Cataluña, Spain, 08003
      • Research Site
    • Barcelona, Cataluña, Spain, 08035
      • Research Site
    • Barcelona, Cataluña, Spain, 08036
      • Research Site
  • Comunidad Valenciana
    • Elche, Comunidad Valenciana, Spain, 03203
      • Research Site
    • Valencia, Comunidad Valenciana, Spain, 46009
      • Research Site
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
      • Research Site
    • Vigo, Galicia, Spain, 36204
      • Research Site
  • PaÃ-s Vasco
    • San Sebastián, PaÃ-s Vasco, Spain, 20014
      • Research Site
• Sweden
  • UmeÃ¥, Sweden, 901 85
    • Research Site
  • Uppsala, Sweden, 751 85
    • Research Site
• Switzerland
  • Baden, Switzerland, 5404
    • Research Site
  • Bellinzona, Switzerland, 6500
    • Research Site
  • Chur, Switzerland, 7000
    • Research Site
  • Geneva 14, Switzerland, 1211
    • Research Site
  • Zurich, Switzerland, 8091
    • Research Site
• United Kingdom
  • London, United Kingdom, NW1 2PG
    • 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
    • Research Site
  • Sutton, United Kingdom, SM2 5PT
    • Research Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Research Site
  • California
    • Los Angeles, California, United States, 90048
      • Research Site
    • San Diego, California, United States, 92121
      • Research Site
    • Stanford, California, United States, 94305
      • Research Site
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Research Site
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Research Site
    • New Haven, Connecticut, United States, 06520
      • Research Site
  • Florida
    • Hollywood, Florida, United States, 33021
      • Research Site
    • Orlando, Florida, United States, 32806
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Research Site
    • Honolulu, Hawaii, United States, 96826
      • Research Site
  • Idaho
    • Boise, Idaho, United States, 83712
      • Research Site
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Research Site
    • Skokie, Illinois, United States, 60076
      • Research Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Research Site
    • Baltimore, Maryland, United States, 21201
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Research Site
    • Boston, Massachusetts, United States, 02118
      • Research Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Research Site
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Research Site
  • New York
    • Brightwaters, New York, United States, 11718
      • Research Site
    • New York, New York, United States, 10032
      • Research Site
    • New York, New York, United States, 10029
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Charlotte, North Carolina, United States, 28203
      • Research Site
    • Winston Salem, North Carolina, United States, 27103
      • Research Site
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
  • Utah
    • Ogden, Utah, United States, 84403
      • Research Site
  • Washington
    • Tacoma, Washington, United States, 98405
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Research Site
    • Milwaukee, Wisconsin, United States, 53215
      • 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 18 years of age or older at the time the written informed consent is obtained
• Gynecologic Oncology Group (GOG) Performance Status of 0 or 1
• Life expectancy >= 3 months (per investigator opinion)
• Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded)
• Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy
• Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications
• Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment.
• Adequate organ and hematological function
• Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and diastolic blood pressure <= 90 mmHg prior to randomization. The use of anti-hypertensive medications to control hypertension is permitted
• Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer

Exclusion Criteria:

• Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers
• Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded
• Subjects with primary platinum-refractory disease
• Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
• Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities
• Previous abdominal or pelvic radiotherapy
• History of arterial or venous thromboembolism within 12 months prior to randomization
• History of clinically significant bleeding within 6 months prior to randomization
• History of central nervous system metastasis
• Has not yet completed a 21 day washout period prior to randomization for any previous anti cancer systemic therapies (30 days for prior bevacizumab)
• Enrolled in or has not yet completed at least 30 days (prior to randomization) since ending other investigational device or drug, or currently receiving other investigational treatments
• Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except alopecia
• Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization
• Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
• Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide
• Clinically significant cardiovascular disease within 12 months prior to randomization
• Major surgery within 28 days prior to randomization or still recovering from prior surgery
• Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMG 386; Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW	Drug: AMG 386; Weekly Intravenous (IV) AMG 386 15 mg/kg; Other Names: Angiogenesis inhibitor; Drug: Paclitaxel; Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off); Other Names: Taxol USPI, 2007; Taxol SPC, 2009
Placebo Comparator: AMG 386 Placebo; Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW	Drug: Paclitaxel; Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off); Other Names: Taxol USPI, 2007; Taxol SPC, 2009; Drug: AMG 386 Placebo; Weekly Intravenous (IV) placebo 15 mg/kg; Other Names: Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-Free Survival	8 Months on average

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	20 months on average
Objective Response Rate	From Baseline (if subject has Measurable Disease) until objective response (radiologic)
Duration of response	From Baseline until progression
CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125	From Baseline until CA-125 response
Incidence of adverse events and significant laboratory abnormalities	8 Months on average
Pharmacokinetics of AMG 386 (Cmax and Cmin)	Week 1 until week 9 of treatment
Incidence of the occurrence of anti-AMG 386 antibody formation	Week 1 until maximum of 1-year following last dose of study drug
Patient reported Health Related Quality of Life (HRQOL) and ovarian cancer related symptoms using Functional Assessment of Cancer Therapy - Ovary questionnaire (FACT-O)	From week 1 until 30-days following last study drug administration
Overall health status using EuroQOL(EQ-5D)	From week 1 until 30-days following last study drug administration

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhomme C, Richardson G, Rincon DG, Coleman RL, Herzog TJ, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Tassoudji M, Navale L, Warner DJ, Oza AM. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014 Jul;15(8):799-808. doi: 10.1016/S1470-2045(14)70244-X. Epub 2014 Jun 17.
• Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhomme C, Richardson G, Rincon DG, Coleman RL, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Ma H, Vogl FD, Bach BA, Oza AM. Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2. Gynecol Oncol. 2016 Oct;143(1):27-34. doi: 10.1016/j.ygyno.2016.07.112. Epub 2016 Aug 18.
• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: September 16, 2010
• First Posted (Estimate): September 17, 2010

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Ovarian Cancer; Paclitaxel; Fallopian Tube Cancer; Angiogenesis Inhibitors; Primary Peritoneal Cancer; AMGEN; AMG 386; TRINOVA-1
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Abdominal Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal 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 Modulating Agents; Growth Substances; Growth Inhibitors; Paclitaxel; Albumin-Bound Paclitaxel; Trebananib; Angiogenesis Inhibitors
• Other Study ID Numbers: 20090508