Fallopian Tube CancerPhase 3NCT01204749
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 study testing AMG 386 and Paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Amgen at 225 sites in 32 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer
- What is being tested?
- AMG 386 and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 919 participants
- Where
- 225 sitesin 32 countries
- Study dates
- Nov 2010to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
225 sites in 32 countries.
225 sites in 32 countries
United States35 sites
Research Site
Abington, Pennsylvania, 19001
Research Site
Baltimore, Maryland, 21201
Research Site
Baltimore, Maryland, 21237
Research Site
Boise, Idaho, 83712
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02118
Research Site
Brightwaters, New York, 11718
Research Site
Charlotte, North Carolina, 28203
Research Site
Charlotte, North Carolina, 28204
Research Site
Chattanooga, Tennessee, 37403
Research Site
Danbury, Connecticut, 06810
Research Site
Englewood, Colorado, 80113
Research Site
Hackensack, New Jersey, 07601
Research Site
Hollywood, Florida, 33021
Research Site
Honolulu, Hawaii, 96819
Research Site
Honolulu, Hawaii, 96826
Research Site
Houston, Texas, 77030
Research Site
Lebanon, New Hampshire, 03756
Research Site
Los Angeles, California, 90048
Research Site
Metairie, Louisiana, 70006
Research Site
Milwaukee, Wisconsin, 53215
Research Site
Milwaukee, Wisconsin, 53226
Research Site
New Haven, Connecticut, 06520
Research Site
New York, New York, 10029
Research Site
New York, New York, 10032
Research Site
Ogden, Utah, 84403
Research Site
Orlando, Florida, 32806
Research Site
Peoria, Illinois, 61615
Research Site
Phoenix, Arizona, 85013
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92121
Research Site
Skokie, Illinois, 60076
Research Site
Stanford, California, 94305
Research Site
Tacoma, Washington, 98405
Research Site
Winston-Salem, North Carolina, 27103
France27 sites
Research Site
Amiens, 80000
Research Site
Angers, 49933
Research Site
Avignon, 84082
Research Site
Bayonne, 64100
Research Site
Besançon, 25030
Research Site
Bordeaux, 33030
Research Site
Bordeaux, 33076
Research Site
Brest, 29609
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Dijon, 21079
Research Site
Le Mans, 72000
Research Site
Lille, 59020
Research Site
Lyon, 69008
Research Site
Marseille, 13009
Research Site
Marseille, 13273
Research Site
Marseille, 13385
Research Site
Montpellier, 34298
Research Site
Nancy, 54100
Research Site
Nantes, 44202
Research Site
Nice, 06189
Research Site
Orléans Cedex 2, 45067
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Périgueux Cedex, 24004
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Paris, 75908
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Reims, 51092
Research Site
Saint Grégoire Cedex, 35768
Research Site
Saint-Herblain, 44800
Research Site
Strasbourg, 67000
Research Site
Villejuif, 94805
Spain20 sites
Research Site
Badalona, Cataluña, 08916
Research Site
Barcelona, Cataluña, 08003
Research Site
Barcelona, Cataluña, 08035
Research Site
Barcelona, Cataluña, 08036
Research Site
Córdoba, AndalucÃ-a, 14004
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Elche, Valencia, 03203
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Huelva, AndalucÃ-a, 21005
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Málaga, AndalucÃ-a, 29010
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Madrid, Madrid, 28009
Research Site
Madrid, Madrid, 28033
Research Site
Madrid, Madrid, 28034
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Madrid, Madrid, 28040
Research Site
Madrid, Madrid, 28046
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Palma de Mallorca, Balearic Islands, 07198
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Salamanca, Castilla León, 37007
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San Sebastián, PaÃ-s Vasco, 20014
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Santiago de Compostela, Galicia, 15706
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Seville, AndalucÃ-a, 41013
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Valencia, Valencia, 46009
Research Site
Vigo, Galicia, 36204
Japan16 sites
Research Site
Chuo-ku, Tokyo, 104-0045
Research Site
Fukuoka, Fukuoka, 811-1395
Research Site
Hidaka-Shi, Saitama, 350-1298
Research Site
Kure, Hiroshima, 737-0023
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Kurume, 830-0011
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Morioka, Iwate, 020-8505
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Nagoya, Aichi-ken, 464-8681
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Niigata, Niigata, 951-8520
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Sapporo, Hokkaido, 104-0045
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Sayama, Osaka, 589-8511
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Suntou-gun, Shizuoka, 411-8777
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Tokyo, 105-8471
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Tokyo, 135-8550
Research Site
Tokyo, 160-8582
Research Site
Tsukuba, Ibaraki, 305-8576
Research Site
Yonago, Tottori, 683-8504
Italy11 sites
Research Site
Benevento, 82100
Research Site
Catania, 95126
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Cosenza (CS), 87100
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Genova, 16121
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Milan, 20133
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Milan, 20141
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Naples, 80131
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Padova, 35128
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Potenza, 85100
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Roma, 00161
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Roma, 00168
Canada8 sites
Research Site
Calgary, Alberta, T2N 4N2
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London, Ontario, N6A 4L6
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Montreal, Quebec, H2L 4M1
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Québec, Quebec, G1R 2J6
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Sherbrooke, Quebec, J1H 5N4
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Toronto, Ontario, M4N 3M5
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Toronto, Ontario, M5G 2M9
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Vancouver, British Columbia, V5Z 4E6
Russia8 sites
Research Site
Ivanovo, 153013
Research Site
Krasnodar, 350040
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Moscow, 115478
Research Site
Obninsk, 249036
Research Site
Pyatigorsk, 357502
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Saint Petersburg, 197022
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Ufa, 450054
Research Site
Voronezh, 394000
Australia7 sites
Research Site
Bendigo, Victoria, 3550
Research Site
Bentleigh East, Victoria, 3165
Research Site
Footscray, Victoria, 3011
Research Site
Greenslopes, Queensland, 4120
Research Site
Malvern, Victoria, 3144
Research Site
New Lambton Heights, New South Wales, 2305
Research Site
Parkville, Victoria, 3052
United Kingdom7 sites
Research Site
London, NW1 2PG
Research Site
London, SW3 6JJ
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Manchester, M20 4BX
Research Site
Northwood, HA6 2RN
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Nottingham, NG5 1PB
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Poole, BH15 2JB
Research Site
Sutton, SM2 5PT
Brazil6 sites
Research Site
ItajaÃ-, Santa Catarina, 88301-220
Research Site
Porto Alegre, Rio Grande do Sul, 90035-003
Research Site
Porto Alegre, Rio Grande do Sul, 91350-200
Research Site
Ribeirão Preto, São Paulo, 14025-270
Research Site
Rio de Janeiro, Rio de Janeiro, 20220-410
Research Site
São Paulo, São Paulo, 01317-000
Poland6 sites
Research Site
Bydgoszcz, 85-796
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Gdansk, 80-219
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Lodz, 94-029
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Lublin, 20-090
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Poznan, 60-535
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Warsaw, 02-781
Portugal6 sites
Research Site
Coimbra, 3000-075
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Guimarães, 4835-044
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Lisbon, 1500-650
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Porto, 4200-072
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Porto, 4200-319
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Santa Maria da Feira, 4520-211
South Africa6 sites
Research Site
Groenkloof, Gauteng, 0181
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Johannesburg, Gauteng, 2199
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Kraaifontein, Western Cape, 7570
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Observatory, 7925
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Port Elizabeth, 6045
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Pretoria, 0002
Bulgaria5 sites
Research Site
Gabrovo, 5300
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Plovdiv, 4004
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Sofia, 1233
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Stara Zagora, 6003
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Varna, 9000
Greece5 sites
Research Site
Athens, 11528
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Heraklion, 71110
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Larissa, 41110
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Pátrai, 26500
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Thessaloniki, 56429
India5 sites
Research Site
Hyderabad, Andhra Pradesh, 500 024
Research Site
Mumbai, Maharashtra, 400 012
Research Site
Nashik, Maharashtra, 422 004
Research Site
Pune, Maharashtra, 411 001
Research Site
Pune, Maharashtra, 411 004
Israel5 sites
Research Site
Haifa, 31096
Research Site
Holon, 58100
Research Site
Kefar Sava, 44281
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Tel Aviv, 64239
Research Site
Tel HaShomer, 52621
Romania5 sites
Research Site
Bucharest, 011172
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Bucharest, 022328
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Cluj-Napoca, 400015
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Suceava, 720237
Research Site
Târgu Mureş, 540142
Switzerland5 sites
Research Site
Baden, 5404
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Bellinzona, 6500
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Chur, 7000
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Geneva, 1211
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Zurich, 8091
Czechia4 sites
Research Site
Brno, 625 00
Research Site
Brno, 656 53
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Prague, 128 51
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Prague, 150 06
Mexico4 sites
Research Site
Distrito Federal, Mexico City, 04380
Research Site
Mexico City, Mexico City, 06726
Research Site
Mexico City, Mexico City, 14080
Research Site
San Luis Potosí City, San Luis PotosÃ-, 78200
South Korea4 sites
Research Site
Goyang-si, Gyeonggi-do, 410-769
Research Site
Seoul, 135-710
Research Site
Seoul, 137-701
Research Site
Seoul, 138-736
Belgium3 sites
Research Site
Edegem, 2650
Research Site
Leuven, 3000
Research Site
Namur, 5000
Latvia3 sites
Research Site
Daugavpils, 5417
Research Site
Riga, 1002
Research Site
Riga, 1079
Malaysia3 sites
Research Site
Johor Bahru, Johor, 81100
Research Site
Kota Bharu, Kelantan, 16150
Research Site
Kuala Lumpur, Kuala Lumpur, 50603
Chile2 sites
Research Site
Temuco, CautÃ-n, 4810469
Research Site
Valparaíso, ValparaÃ-so, 2363058
Peru2 sites
Research Site
Lima, Lima Province, 11
Research Site
Lima, Lima Province, 31
About this study
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
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.
- Being tested
- AMG 386, AMG 386 Placebo, Paclitaxel
- Keywords
- AMGEN, AMG 386, Angiogenesis Inhibitors, Fallopian Tube Cancer, Primary Peritoneal Cancer, Paclitaxel, Ovarian Cancer, TRINOVA-1
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 386Drug
Also called Angiogenesis inhibitor
Weekly Intravenous (IV) AMG 386 15 mg/kg
AMG 386 PlaceboDrug
Also called Placebo comparator
Weekly Intravenous (IV) placebo 15 mg/kg
PaclitaxelDrug
Also called Taxol USPI, 2007; Taxol SPC, 2009
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
PaclitaxelDrug
Also called Taxol USPI, 2007; Taxol SPC, 2009
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
| Study group | Role | What they receive |
|---|---|---|
| AMG 386 | Experimental | Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW Receives: Drug: AMG 386; Drug: Paclitaxel |
| AMG 386 Placebo | Placebo comparator | Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW Receives: Drug: AMG 386 Placebo; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Measured: 8 Months on average
Secondary outcomes (9)
Overall survival
Measured: 20 months on average
Objective Response Rate
Measured: From Baseline (if subject has Measurable Disease) until objective response (radiologic)
Duration of response
Measured: From Baseline until progression
CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125
Measured: From Baseline until CA-125 response
Incidence of adverse events and significant laboratory abnormalities
Measured: 8 Months on average
Pharmacokinetics of AMG 386 (Cmax and Cmin)
Measured: Week 1 until week 9 of treatment
Incidence of the occurrence of anti-AMG 386 antibody formation
Measured: 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)
Measured: From week 1 until 30-days following last study drug administration
Overall health status using EuroQOL(EQ-5D)
Measured: From week 1 until 30-days following last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2013
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 919 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204749
- Sponsor's protocol ID
- 20090508
- Status last verified
- Dec 2016
- First submitted
- 26 Aug 2010
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24950985Monk 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.
PubMed 27546885Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961Fujiwara 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.
PubMed 27029706
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01204749
- Acronym / sponsor ID
- 20090508
- Keywords
- AMGEN, AMG 386, Angiogenesis Inhibitors, Fallopian Tube Cancer, Primary Peritoneal Cancer, Paclitaxel, Ovarian Cancer, TRINOVA-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 919 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 386 | Experimental | Drug: AMG 386, Drug: PaclitaxelArm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW |
| AMG 386 Placebo | Placebo comparator | Drug: AMG 386 Placebo, Drug: PaclitaxelArm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 386Also: Angiogenesis inhibitorWeekly Intravenous (IV) AMG 386 15 mg/kg | Drug | AMG 386 |
| AMG 386 PlaceboAlso: Placebo comparatorWeekly Intravenous (IV) placebo 15 mg/kg | Drug | AMG 386 Placebo |
| PaclitaxelAlso: Taxol USPI, 2007; Taxol SPC, 2009Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off) | Drug | AMG 386 |
| PaclitaxelAlso: Taxol USPI, 2007; Taxol SPC, 2009Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off) | Drug | AMG 386 Placebo |
Primary outcome
Progression-Free Survival
Time frame: 8 Months on average
9 secondary outcomes
Overall survival
Time frame: 20 months on average
Objective Response Rate
Time frame: From Baseline (if subject has Measurable Disease) until objective response (radiologic)
Duration of response
Time frame: From Baseline until progression
CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125
Time frame: From Baseline until CA-125 response
Incidence of adverse events and significant laboratory abnormalities
Time frame: 8 Months on average
Pharmacokinetics of AMG 386 (Cmax and Cmin)
Time frame: Week 1 until week 9 of treatment
Incidence of the occurrence of anti-AMG 386 antibody formation
Time frame: 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)
Time frame: From week 1 until 30-days following last study drug administration
Overall health status using EuroQOL(EQ-5D)
Time frame: From week 1 until 30-days following last study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Background: PubMed 24950985Monk 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.
- Background: PubMed 27546885Monk 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.
- Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
- Derived from this study: PubMed 27029706Fujiwara 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
225 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AMG 386 and Paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Amgen at 225 sites in 32 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 225 sites in United States, France, Spain, Japan, Italy and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 8 Months on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01204749, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.