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
NCT ID: NCT01204749
Last Updated: 2016-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
919 participants
INTERVENTIONAL
2010-11-30
2016-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AMG 386
Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW
AMG 386
Weekly Intravenous (IV) AMG 386 15 mg/kg
Paclitaxel
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
AMG 386 Placebo
Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW
AMG 386 Placebo
Weekly Intravenous (IV) placebo 15 mg/kg
Paclitaxel
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
Interventions
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AMG 386
Weekly Intravenous (IV) AMG 386 15 mg/kg
AMG 386 Placebo
Weekly Intravenous (IV) placebo 15 mg/kg
Paclitaxel
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
Paclitaxel
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Stanford, California, United States
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Englewood, Colorado, United States
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Danbury, Connecticut, United States
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New Haven, Connecticut, United States
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Hollywood, Florida, United States
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Orlando, Florida, United States
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Honolulu, Hawaii, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Peoria, Illinois, United States
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Skokie, Illinois, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Lebanon, New Hampshire, United States
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Hackensack, New Jersey, United States
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Brightwaters, New York, United States
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New York, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Abington, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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New Lambton Heights, New South Wales, Australia
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Greenslopes, Queensland, Australia
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Bendigo, Victoria, Australia
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Bentleigh East, Victoria, Australia
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Footscray, Victoria, Australia
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Malvern, Victoria, Australia
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Parkville, Victoria, Australia
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Edegem, , Belgium
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Leuven, , Belgium
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Namur, , Belgium
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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ItajaÃ-, Santa Catarina, Brazil
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Ribeirão Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Gabrovo, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Temuco, CautÃ-n, Chile
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Valparaíso, ValparaÃ-so, Chile
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Zagreb, , Croatia
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Brno, , Czechia
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Brno, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Tallinn, , Estonia
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Tartu, , Estonia
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Amiens, , France
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Angers, , France
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Avignon, , France
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Bayonne, , France
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Besançon, , France
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Bordeaux, , France
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Bordeaux, , France
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Brest, , France
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Dijon, , France
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Le Mans, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Marseille, , France
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Marseille, , France
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Montpellier, , France
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Nancy, , France
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Nantes, , France
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Nice, , France
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Orléans Cedex 2, , France
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Paris, , France
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Périgueux Cedex, , France
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Reims, , France
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Saint Grégoire Cedex, , France
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Saint-Herblain, , France
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Strasbourg, , France
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Villejuif, , France
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Athens, , Greece
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Heraklion, , Greece
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Larissa, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Hyderabad, Andhra Pradesh, India
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Mumbai, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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Haifa, , Israel
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Holon, , Israel
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Kefar Sava, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Benevento, , Italy
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Catania, , Italy
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Cosenza (CS), , Italy
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Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Potenza, , Italy
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Roma, , Italy
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Roma, , Italy
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Nagoya, Aichi-ken, Japan
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Fukuoka, Fukuoka, Japan
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Kure, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Tsukuba, Ibaraki, Japan
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Morioka, Iwate, Japan
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Niigata, Niigata, Japan
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Sayama, Osaka, Japan
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Hidaka-Shi, Saitama, Japan
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Suntou-gun, Shizuoka, Japan
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Chuo-ku, Tokyo, Japan
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Yonago, Tottori, Japan
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Kurume, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Daugavpils, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Johor Bahru, Johor, Malaysia
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Kota Bharu, Kelantan, Malaysia
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Distrito Federal, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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San Luis Potosí City, San Luis PotosÃ-, Mexico
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Coimbra, , Portugal
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Guimarães, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Santa Maria da Feira, , Portugal
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Suceava, , Romania
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Târgu Mureş, , Romania
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Ivanovo, , Russia
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Krasnodar, , Russia
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Moscow, , Russia
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Obninsk, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Ufa, , Russia
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Voronezh, , Russia
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Ljubljana, , Slovenia
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Groenkloof, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Kraaifontein, Western Cape, South Africa
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Observatory, , South Africa
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Port Elizabeth, , South Africa
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Pretoria, , South Africa
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Goyang-si, Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Córdoba, AndalucÃ-a, Spain
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Huelva, AndalucÃ-a, Spain
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Málaga, AndalucÃ-a, Spain
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Seville, AndalucÃ-a, Spain
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Palma de Mallorca, Balearic Islands, Spain
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Salamanca, Castilla León, Spain
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Badalona, Cataluña, Spain
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Barcelona, Cataluña, Spain
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Barcelona, Cataluña, Spain
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Barcelona, Cataluña, Spain
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Santiago de Compostela, Galicia, Spain
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Vigo, Galicia, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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San Sebastián, PaÃ-s Vasco, Spain
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Elche, Valencia, Spain
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Valencia, Valencia, Spain
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Umeå, , Sweden
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Uppsala, , Sweden
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Baden, , Switzerland
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Bellinzona, , Switzerland
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Chur, , Switzerland
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Geneva, , Switzerland
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Zurich, , Switzerland
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Northwood, , United Kingdom
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Nottingham, , United Kingdom
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Poole, , United Kingdom
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Sutton, , United Kingdom
Countries
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References
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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.
Gaitskell 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.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20090508
Identifier Type: -
Identifier Source: org_study_id