Ovarian Cancer Clinical Trial
AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)
Summary
To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)
The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer
Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer
Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
Female 18 years of age or older at the time the written informed consent is obtained
Adequate organ and hematological function
Exclusion Criteria:
Subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy
Subjects with primary platinum-refractory disease
Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
History of central nervous system metastasis
Major surgery within 28 days prior to randomization or still recovering from prior surgery
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There are 103 Locations for this study
Los Angeles California, 90027, United States
San Francisco California, 94143, United States
Norwalk Connecticut, 06856, United States
Stamford Connecticut, 06902, United States
Orlando Florida, 32806, United States
Tampa Florida, 33612, United States
Evanston Illinois, 60201, United States
Saint Louis Park Minnesota, 55426, United States
New York New York, 10029, United States
Asheville North Carolina, 28806, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27103, United States
Bismarck North Dakota, 58501, United States
Abington Pennsylvania, 19001, United States
Sioux Falls South Dakota, 57104, United States
Fort Sam Houston Texas, 78234, United States
San Antonio Texas, 78229, United States
Annandale Virginia, 22003, United States
Green Bay Wisconsin, 54301, United States
Milwaukee Wisconsin, 53215, United States
West Allis Wisconsin, 53227, United States
New Lambton Heights New South Wales, 2305, Australia
Wahroonga New South Wales, 2076, Australia
Auchenflower Queensland, 4066, Australia
Greenslopes Queensland, 4120, Australia
East Bentleigh Victoria, 3165, Australia
Footscray Victoria, 3011, Australia
Malvern Victoria, 3144, Australia
Parkville Victoria, 3052, Australia
Graz , 8020, Austria
Graz , 8036, Austria
Innsbruck , 6020, Austria
Linz , 4010, Austria
Wien , 1090, Austria
Wien , 1160, Austria
Charleroi , 6000, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Ieper , 8900, Belgium
Leuven , 3000, Belgium
Libramont , 6800, Belgium
Liège , 4000, Belgium
Namur , 5000, Belgium
London Ontario, N6A 4, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Herlev , 2730, Denmark
København , 2100, Denmark
Amiens , 80000, France
Avignon cedex 9 , 84918, France
Lyon cedex 8 , 69373, France
Poitiers , 86021, France
Saint Cloud , 92210, France
Berlin , 13353, Germany
Bonn , 53105, Germany
Düsseldorf , 40217, Germany
Erlangen , 91054, Germany
Essen , 45136, Germany
Frankfurt am Main , 60590, Germany
Freiburg , 79106, Germany
Hannover , 30177, Germany
Marburg , 35043, Germany
München , 81377, Germany
München , 81675, Germany
Rostock , 18059, Germany
Tübingen , 72076, Germany
Hong Kong , , Hong Kong
New Territories , , Hong Kong
Budapest , 1032, Hungary
Budapest , 1062, Hungary
Debrecen , 4032, Hungary
Miskolc , 3526, Hungary
Szeged , 6720, Hungary
Zalaegerszeg - Pozva , 8900, Hungary
Campobasso , 86100, Italy
Genova , 16128, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Roma , 00128, Italy
Roma , 00161, Italy
Roma , 00168, Italy
Grafton, Auckland , 1023, New Zealand
Tauranga , 3143, New Zealand
Bialystok , 15-02, Poland
Gdansk , 80-21, Poland
Singapore , 16961, Singapore
Singapore , 22989, Singapore
Bratislava , 812 5, Slovakia
Bratislava , 831 0, Slovakia
Kosice , 041 9, Slovakia
Presov , 080 0, Slovakia
Aarau , 5001, Switzerland
Chur , 7000, Switzerland
Geneva 14 , 1211, Switzerland
Zurich , 8091, Switzerland
Tainan , 70403, Taiwan
Taipei , 10041, Taiwan
Taipei , 10449, Taiwan
London , NW1 2, United Kingdom
London , SE1 9, United Kingdom
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Northwood , HA6 2, United Kingdom
Nottingham , NG5 1, United Kingdom
Poole , BH15 , United Kingdom
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