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
1 other identifier
interventional
919
31 countries
223
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2010
Longer than P75 for phase_3
223 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 15, 2016
December 1, 2016
2.3 years
August 26, 2010
December 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival
8 Months on average
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
AMG 386
EXPERIMENTALArm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW
AMG 386 Placebo
PLACEBO COMPARATORArm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW
Interventions
Weekly Intravenous (IV) placebo 15 mg/kg
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (225)
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Phoenix, Arizona, 85013, United States
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Los Angeles, California, 90048, United States
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San Diego, California, 92121, United States
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Stanford, California, 94305, United States
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Englewood, Colorado, 80113, United States
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Danbury, Connecticut, 06810, United States
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New Haven, Connecticut, 06520, United States
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Hollywood, Florida, 33021, United States
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Orlando, Florida, 32806, United States
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Honolulu, Hawaii, 96819, United States
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Honolulu, Hawaii, 96826, United States
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Boise, Idaho, 83712, United States
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Peoria, Illinois, 61615, United States
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Skokie, Illinois, 60076, United States
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Metairie, Louisiana, 70006, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21237, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02118, United States
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Lebanon, New Hampshire, 03756, United States
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Hackensack, New Jersey, 07601, United States
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Brightwaters, New York, 11718, United States
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New York, New York, 10029, United States
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New York, New York, 10032, United States
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Charlotte, North Carolina, 28203, United States
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Charlotte, North Carolina, 28204, United States
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Winston-Salem, North Carolina, 27103, United States
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Abington, Pennsylvania, 19001, United States
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Chattanooga, Tennessee, 37403, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Ogden, Utah, 84403, United States
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Tacoma, Washington, 98405, United States
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Milwaukee, Wisconsin, 53215, United States
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Milwaukee, Wisconsin, 53226, United States
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New Lambton Heights, New South Wales, 2305, Australia
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Greenslopes, Queensland, 4120, Australia
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Bendigo, Victoria, 3550, Australia
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Bentleigh East, Victoria, 3165, Australia
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Footscray, Victoria, 3011, Australia
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Malvern, Victoria, 3144, Australia
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Parkville, Victoria, 3052, Australia
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Namur, 5000, Belgium
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Rio de Janeiro, Rio de Janeiro, 20220-410, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
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Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
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ItajaÃ-, Santa Catarina, 88301-220, Brazil
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Ribeirão Preto, São Paulo, 14025-270, Brazil
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São Paulo, São Paulo, 01317-000, Brazil
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Gabrovo, 5300, Bulgaria
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Plovdiv, 4004, Bulgaria
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Sofia, 1233, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Varna, 9000, Bulgaria
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Calgary, Alberta, T2N 4N2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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London, Ontario, N6A 4L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Québec, Quebec, G1R 2J6, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Temuco, CautÃ-n, 4810469, Chile
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Valparaíso, ValparaÃ-so, 2363058, Chile
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Zagreb, 10000, Croatia
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Brno, 625 00, Czechia
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Brno, 656 53, Czechia
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Prague, 128 51, Czechia
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Prague, 150 06, Czechia
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Tallinn, 13419, Estonia
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Tartu, 51014, Estonia
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Amiens, 80000, France
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Angers, 49933, France
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Avignon, 84082, France
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Bayonne, 64100, France
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Besançon, 25030, France
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Bordeaux, 33030, France
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Bordeaux, 33076, France
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Brest, 29609, France
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Dijon, 21079, France
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Le Mans, 72000, France
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Lille, 59020, France
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Lyon, 69008, France
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Marseille, 13009, France
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Marseille, 13273, France
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Marseille, 13385, France
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Montpellier, 34298, France
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Nancy, 54100, France
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Nantes, 44202, France
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Nice, 06189, France
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Orléans Cedex 2, 45067, France
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Paris, 75908, France
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Périgueux Cedex, 24004, France
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Reims, 51092, France
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Saint Grégoire Cedex, 35768, France
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Saint-Herblain, 44800, France
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Strasbourg, 67000, France
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Villejuif, 94805, France
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Athens, 11528, Greece
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Heraklion, 71110, Greece
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Larissa, 41110, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 56429, Greece
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Hong Kong, Hong Kong
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Hyderabad, Andhra Pradesh, 500 024, India
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Mumbai, Maharashtra, 400 012, India
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Nashik, Maharashtra, 422 004, India
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Pune, Maharashtra, 411 001, India
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Pune, Maharashtra, 411 004, India
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Haifa, 31096, Israel
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Holon, 58100, Israel
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Kefar Sava, 44281, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Benevento, 82100, Italy
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Catania, 95126, Italy
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Cosenza (CS), 87100, Italy
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Genova, 16121, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Potenza, 85100, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Nagoya, Aichi-ken, 464-8681, Japan
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Fukuoka, Fukuoka, 811-1395, Japan
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Kure, Hiroshima, 737-0023, Japan
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Sapporo, Hokkaido, 104-0045, Japan
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Tsukuba, Ibaraki, 305-8576, Japan
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Morioka, Iwate, 020-8505, Japan
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Niigata, Niigata, 951-8520, Japan
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Sayama, Osaka, 589-8511, Japan
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Hidaka-Shi, Saitama, 350-1298, Japan
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Suntou-gun, Shizuoka, 411-8777, Japan
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Chuo-ku, Tokyo, 104-0045, Japan
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Yonago, Tottori, 683-8504, Japan
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Kurume, 830-0011, Japan
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Tokyo, 105-8471, Japan
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Tokyo, 135-8550, Japan
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Tokyo, 160-8582, Japan
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Daugavpils, 5417, Latvia
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Riga, 1002, Latvia
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Riga, 1079, Latvia
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Johor Bahru, Johor, 81100, Malaysia
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Kota Bharu, Kelantan, 16150, Malaysia
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Kuala Lumpur, Kuala Lumpur, 50603, Malaysia
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Distrito Federal, Mexico City, 04380, Mexico
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Mexico City, Mexico City, 06726, Mexico
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Mexico City, Mexico City, 14080, Mexico
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San Luis Potosí City, San Luis PotosÃ-, 78200, Mexico
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Lima, Lima Province, 11, Peru
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Lima, Lima Province, 31, Peru
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Bydgoszcz, 85-796, Poland
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Gdansk, 80-219, Poland
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Lodz, 94-029, Poland
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Lublin, 20-090, Poland
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Poznan, 60-535, Poland
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Warsaw, 02-781, Poland
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Coimbra, 3000-075, Portugal
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Guimarães, 4835-044, Portugal
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Lisbon, 1500-650, Portugal
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Porto, 4200-072, Portugal
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Porto, 4200-319, Portugal
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Santa Maria da Feira, 4520-211, Portugal
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Bucharest, 011172, Romania
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Bucharest, 022328, Romania
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Cluj-Napoca, 400015, Romania
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Suceava, 720237, Romania
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Târgu Mureş, 540142, Romania
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Ivanovo, 153013, Russia
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Krasnodar, 350040, Russia
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Moscow, 115478, Russia
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Obninsk, 249036, Russia
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Pyatigorsk, 357502, Russia
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Saint Petersburg, 197022, Russia
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Ufa, 450054, Russia
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Voronezh, 394000, Russia
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Ljubljana, 1000, Slovenia
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Groenkloof, Gauteng, 0181, South Africa
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Johannesburg, Gauteng, 2199, South Africa
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Kraaifontein, Western Cape, 7570, South Africa
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Observatory, 7925, South Africa
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Port Elizabeth, 6045, South Africa
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Pretoria, 0002, South Africa
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Goyang-si, Gyeonggi-do, 410-769, South Korea
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Seoul, 135-710, South Korea
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Seoul, 137-701, South Korea
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Seoul, 138-736, South Korea
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Córdoba, AndalucÃ-a, 14004, Spain
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Huelva, AndalucÃ-a, 21005, Spain
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Málaga, AndalucÃ-a, 29010, Spain
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Seville, AndalucÃ-a, 41013, Spain
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Palma de Mallorca, Balearic Islands, 07198, Spain
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Salamanca, Castilla León, 37007, Spain
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Badalona, Cataluña, 08916, Spain
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Barcelona, Cataluña, 08003, Spain
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Barcelona, Cataluña, 08035, Spain
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Barcelona, Cataluña, 08036, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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Vigo, Galicia, 36204, Spain
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Madrid, Madrid, 28009, Spain
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Madrid, Madrid, 28033, Spain
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Madrid, Madrid, 28034, Spain
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Madrid, Madrid, 28040, Spain
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Madrid, Madrid, 28046, Spain
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San Sebastián, PaÃ-s Vasco, 20014, Spain
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Elche, Valencia, 03203, Spain
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Valencia, Valencia, 46009, Spain
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Umeå, 901 85, Sweden
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Uppsala, 751 85, Sweden
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Baden, 5404, Switzerland
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Bellinzona, 6500, Switzerland
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Chur, 7000, Switzerland
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Geneva, 1211, Switzerland
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Zurich, 8091, Switzerland
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London, NW1 2PG, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Poole, BH15 2JB, United Kingdom
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Sutton, SM2 5PT, United Kingdom
Related Publications (4)
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.
PMID: 24950985BACKGROUNDMonk 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.
PMID: 27546885BACKGROUNDGaitskell 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.
PMID: 37185961DERIVEDFujiwara 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.
PMID: 27029706DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2010
First Posted
September 17, 2010
Study Start
November 1, 2010
Primary Completion
March 1, 2013
Study Completion
December 1, 2016
Last Updated
December 15, 2016
Record last verified: 2016-12