Clincosm LogoSign in Get a demo

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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT01204749
Collaborator
(none)
919
Enrollment
225
Locations
2
Arms
73
Duration (Months)
4.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
919 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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: AMG 386 Placebo
    Weekly Intravenous (IV) placebo 15 mg/kg
    Other Names:
  • Placebo comparator

    • Drug: Paclitaxel
    Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
    Other Names:
  • Taxol USPI, 2007; Taxol SPC, 2009

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival [8 Months on average]

    Secondary Outcome Measures

    1. Overall survival [20 months on average]

    2. Objective Response Rate [From Baseline (if subject has Measurable Disease) until objective response (radiologic)]

    3. Duration of response [From Baseline until progression]

    4. CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125 [From Baseline until CA-125 response]

    5. Incidence of adverse events and significant laboratory abnormalities [8 Months on average]

    6. Pharmacokinetics of AMG 386 (Cmax and Cmin) [Week 1 until week 9 of treatment]

    7. Incidence of the occurrence of anti-AMG 386 antibody formation [Week 1 until maximum of 1-year following last dose of study drug]

    8. 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]

    9. Overall health status using EuroQOL(EQ-5D) [From week 1 until 30-days following last study drug administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Phoenix Arizona United States 85013
    2 Research Site Los Angeles California United States 90048
    3 Research Site San Diego California United States 92121
    4 Research Site Stanford California United States 94305
    5 Research Site Englewood Colorado United States 80113
    6 Research Site Danbury Connecticut United States 06810
    7 Research Site New Haven Connecticut United States 06520
    8 Research Site Hollywood Florida United States 33021
    9 Research Site Orlando Florida United States 32806
    10 Research Site Honolulu Hawaii United States 96819
    11 Research Site Honolulu Hawaii United States 96826
    12 Research Site Boise Idaho United States 83712
    13 Research Site Peoria Illinois United States 61615
    14 Research Site Skokie Illinois United States 60076
    15 Research Site Metairie Louisiana United States 70006
    16 Research Site Baltimore Maryland United States 21201
    17 Research Site Baltimore Maryland United States 21237
    18 Research Site Boston Massachusetts United States 02114
    19 Research Site Boston Massachusetts United States 02118
    20 Research Site Lebanon New Hampshire United States 03756
    21 Research Site Hackensack New Jersey United States 07601
    22 Research Site Brightwaters New York United States 11718
    23 Research Site New York New York United States 10029
    24 Research Site New York New York United States 10032
    25 Research Site Charlotte North Carolina United States 28203
    26 Research Site Charlotte North Carolina United States 28204
    27 Research Site Winston Salem North Carolina United States 27103
    28 Research Site Abington Pennsylvania United States 19001
    29 Research Site Chattanooga Tennessee United States 37403
    30 Research Site Houston Texas United States 77030
    31 Research Site San Antonio Texas United States 78229
    32 Research Site Ogden Utah United States 84403
    33 Research Site Tacoma Washington United States 98405
    34 Research Site Milwaukee Wisconsin United States 53215
    35 Research Site Milwaukee Wisconsin United States 53226
    36 Research Site New Lambton Heights New South Wales Australia 2305
    37 Research Site Greenslopes Queensland Australia 4120
    38 Research Site Bendigo Victoria Australia 3550
    39 Research Site Bentleigh East Victoria Australia 3165
    40 Research Site Footscray Victoria Australia 3011
    41 Research Site Malvern Victoria Australia 3144
    42 Research Site Parkville Victoria Australia 3052
    43 Research Site Edegem Belgium 2650
    44 Research Site Leuven Belgium 3000
    45 Research Site Namur Belgium 5000
    46 Research Site Porto Alegre Rio Grande do Sul Brazil 90035-003
    47 Research Site Porto Alegre Rio Grande do Sul Brazil 91350-200
    48 Research Site ItajaÃ- Santa Catarina Brazil 88301-220
    49 Research Site Ribeirao Preto São Paulo Brazil 14025-270
    50 Research Site Rio de Janeiro Brazil 20220-410
    51 Research Site São Paulo Brazil 01317-000
    52 Research Site Gabrovo Bulgaria 5300
    53 Research Site Plovdiv Bulgaria 4004
    54 Research Site Sofia Bulgaria 1233
    55 Research Site Stara Zagora Bulgaria 6003
    56 Research Site Varna Bulgaria 9000
    57 Research Site Calgary Alberta Canada T2N 4N2
    58 Research Site Vancouver British Columbia Canada V5Z 4E6
    59 Research Site London Ontario Canada N6A 4L6
    60 Research Site Toronto Ontario Canada M4N 3M5
    61 Research Site Toronto Ontario Canada M5G 2M9
    62 Research Site Montreal Quebec Canada H2L 4M1
    63 Research Site Sherbrooke Quebec Canada J1H 5N4
    64 Research Site Quebec Canada G1R 2J6
    65 Research Site Temuco CautÃ-n Chile 4810469
    66 Research Site Valparaiso ValparaÃ-so Chile 2363058
    67 Research Site Zagreb Croatia 10000
    68 Research Site Brno Czech Republic 625 00
    69 Research Site Brno Czech Republic 656 53
    70 Research Site Praha 2 Czech Republic 128 51
    71 Research Site Praha 5 Czech Republic 150 06
    72 Research Site Tallinn Estonia 13419
    73 Research Site Tartu Estonia 51014
    74 Research Site Amiens France 80000
    75 Research Site Angers France 49933
    76 Research Site Avignon Cedex 2 France 84082
    77 Research Site Bayonne France 64100
    78 Research Site Besancon Cedex France 25030
    79 Research Site Bordeaux Cedex France 33030
    80 Research Site Bordeaux Cedex France 33076
    81 Research Site Brest Cedex 2 France 29609
    82 Research Site Dijon France 21079
    83 Research Site Le Mans France 72000
    84 Research Site Lille Cedex France 59020
    85 Research Site Lyon France 69008
    86 Research Site Marseille cedex 05 France 13385
    87 Research Site Marseille Cedex 09 France 13273
    88 Research Site Marseille France 13009
    89 Research Site Montpellier Cedex 5 France 34298
    90 Research Site Nancy France 54100
    91 Research Site Nantes Cedex 2 France 44202
    92 Research Site Nice cedex 2 France 06189
    93 Research Site Orléans cedex 2 France 45067
    94 Research Site Paris cedex 15 France 75908
    95 Research Site Périgueux cedex France 24004
    96 Research Site Reims Cedex France 51092
    97 Research Site Saint Grégoire cedex France 35768
    98 Research Site Saint Herblain France 44800
    99 Research Site Strasbourg France 67000
    100 Research Site Villejuif cedex France 94805
    101 Research Site Athens Greece 11528
    102 Research Site Heraklion Greece 71110
    103 Research Site Larissa Greece 41110
    104 Research Site Patra Greece 26500
    105 Research Site Thessaloniki Greece 56429
    106 Research Site Hong Kong Hong Kong
    107 Research Site Hyderabad Andhra Pradesh India 500 024
    108 Research Site Mumbai Maharashtra India 400 012
    109 Research Site Nashik Maharashtra India 422 004
    110 Research Site Pune Maharashtra India 411 001
    111 Research Site Pune Maharashtra India 411 004
    112 Research Site Haifa Israel 31096
    113 Research Site Holon Israel 58100
    114 Research Site Kefar Sava Israel 44281
    115 Research Site Tel Hashomer Israel 52621
    116 Research Site Tel-Aviv Israel 64239
    117 Research Site Benevento Italy 82100
    118 Research Site Catania Italy 95126
    119 Research Site Cosenza (CS) Italy 87100
    120 Research Site Genova Italy 16121
    121 Research Site Milano Italy 20133
    122 Research Site Milano Italy 20141
    123 Research Site Napoli Italy 80131
    124 Research Site Padova Italy 35128
    125 Research Site Potenza Italy 85100
    126 Research Site Roma Italy 00161
    127 Research Site Roma Italy 00168
    128 Research Site Nagoya-city Aichi Japan 464-8681
    129 Research Site Fukuoka-shi Fukuoka Japan 811-1395
    130 Research Site Kure-city Hiroshima Japan 737-0023
    131 Research Site Sapporo-city Hokkaido Japan 104-0045
    132 Research Site Tsukuba-city Ibaraki Japan 305-8576
    133 Research Site Morioka-city Iwate Japan 020-8505
    134 Research Site Niigata-city Niigata Japan 951-8520
    135 Research Site Osakasayama-city Osaka Japan 589-8511
    136 Research Site Hidaka-Shi Saitama Japan 350-1298
    137 Research Site Suntou-gun Shizuoka Japan 411-8777
    138 Research Site Chuo-ku Tokyo Japan 104-0045
    139 Research Site Yonago-city Tottori Japan 683-8504
    140 Research Site Kurume-city Japan 830-0011
    141 Research Site Tokyo Japan 105-8471
    142 Research Site Tokyo Japan 135-8550
    143 Research Site Tokyo Japan 160-8582
    144 Research Site Goyang-si, Gyeonggi-do Korea, Republic of 410-769
    145 Research Site Seoul Korea, Republic of 135-710
    146 Research Site Seoul Korea, Republic of 137-701
    147 Research Site Seoul Korea, Republic of 138-736
    148 Research Site Daugavpils Latvia 5417
    149 Research Site Riga Latvia 1002
    150 Research Site Riga Latvia 1079
    151 Research Site Johor Bahru Johor Malaysia 81100
    152 Research Site Kota Bahru Kelantan Malaysia 16150
    153 Research Site Kuala Lumpur Wilayah Persekutuan Malaysia 50603
    154 Research Site Mexico City Distrito Federal Mexico 06726
    155 Research Site Mexico City Distrito Federal Mexico 14080
    156 Research Site San Luis Potosi San Luis PotosÃ- Mexico 78200
    157 Research Site Distrito Federal Mexico 04380
    158 Research Site Lima Peru 11
    159 Research Site Lima Peru 31
    160 Research Site Bydgoszcz Poland 85-796
    161 Research Site Gdansk Poland 80-219
    162 Research Site Lodz Poland 94-029
    163 Research Site Lublin Poland 20-090
    164 Research Site Poznan Poland 60-535
    165 Research Site Warszawa Poland 02-781
    166 Research Site Coimbra Portugal 3000-075
    167 Research Site Guimaraes Portugal 4835-044
    168 Research Site Lisboa Portugal 1500-650
    169 Research Site Porto Portugal 4200-072
    170 Research Site Porto Portugal 4200-319
    171 Research Site Santa Maria da Feira Portugal 4520-211
    172 Research Site Bucharest Romania 011172
    173 Research Site Bucharest Romania 022328
    174 Research Site Cluj Napoca Romania 400015
    175 Research Site Suceava Romania 720237
    176 Research Site Targu Mures Romania 540142
    177 Research Site Ivanovo Russian Federation 153013
    178 Research Site Krasnodar Russian Federation 350040
    179 Research Site Moscow Russian Federation 115478
    180 Research Site Obninsk Russian Federation 249036
    181 Research Site Pyatigorsk Russian Federation 357502
    182 Research Site Saint Petersburg Russian Federation 197022
    183 Research Site Ufa Russian Federation 450054
    184 Research Site Voronezh Russian Federation 394000
    185 Research Site Ljubljana Slovenia 1000
    186 Research Site Groenkloof Gauteng South Africa 0181
    187 Research Site Johannesburg Gauteng South Africa 2199
    188 Research Site Kraaifontein Western Cape South Africa 7570
    189 Research Site Observatory South Africa 7925
    190 Research Site Port Elizabeth South Africa 6045
    191 Research Site Pretoria South Africa 0002
    192 Research Site Córdoba AndalucÃ-a Spain 14004
    193 Research Site Huelva AndalucÃ-a Spain 21005
    194 Research Site Málaga AndalucÃ-a Spain 29010
    195 Research Site Sevilla AndalucÃ-a Spain 41013
    196 Research Site Palma de Mallorca Baleares Spain 07198
    197 Research Site Salamanca Castilla León Spain 37007
    198 Research Site Badalona Cataluña Spain 08916
    199 Research Site Barcelona Cataluña Spain 08003
    200 Research Site Barcelona Cataluña Spain 08035
    201 Research Site Barcelona Cataluña Spain 08036
    202 Research Site Elche Comunidad Valenciana Spain 03203
    203 Research Site Valencia Comunidad Valenciana Spain 46009
    204 Research Site Santiago de Compostela Galicia Spain 15706
    205 Research Site Vigo Galicia Spain 36204
    206 Research Site San Sebastián PaÃ-s Vasco Spain 20014
    207 Research Site Madrid Spain 28009
    208 Research Site Madrid Spain 28033
    209 Research Site Madrid Spain 28034
    210 Research Site Madrid Spain 28040
    211 Research Site Madrid Spain 28046
    212 Research Site Umeå Sweden 901 85
    213 Research Site Uppsala Sweden 751 85
    214 Research Site Baden Switzerland 5404
    215 Research Site Bellinzona Switzerland 6500
    216 Research Site Chur Switzerland 7000
    217 Research Site Geneva 14 Switzerland 1211
    218 Research Site Zurich Switzerland 8091
    219 Research Site London United Kingdom NW1 2PG
    220 Research Site London United Kingdom SW3 6JJ
    221 Research Site Manchester United Kingdom M20 4BX
    222 Research Site Northwood United Kingdom HA6 2RN
    223 Research Site Nottingham United Kingdom NG5 1PB
    224 Research Site Poole United Kingdom BH15 2JB
    225 Research Site Sutton United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT01204749
    Other Study ID Numbers:
    • 20090508
    First Posted:
    Sep 17, 2010
    Last Update Posted:
    Dec 15, 2016
    Last Verified:
    Dec 1, 2016
    Keywords provided by Amgen
    AMGEN
    AMG 386
    Angiogenesis Inhibitors
    Fallopian Tube Cancer
    Primary Peritoneal Cancer
    Paclitaxel
    Ovarian Cancer
    TRINOVA-1
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Fallopian Tube Neoplasms
    Peritoneal Neoplasms
    Paclitaxel
    Albumin-Bound Paclitaxel
    Trebananib
    Angiogenesis Inhibitors

    Study Results

    No Results Posted as of Dec 15, 2016