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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

223

Study ID:

NCT01281254

Recruitment Status:

Terminated

Sponsor:

Amgen

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There are 103 Locations for this study

See Locations Near You

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Los Angeles California, 90027, United States
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San Francisco California, 94143, United States
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Norwalk Connecticut, 06856, United States
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Stamford Connecticut, 06902, United States
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Orlando Florida, 32806, United States
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Tampa Florida, 33612, United States
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Evanston Illinois, 60201, United States
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Saint Louis Park Minnesota, 55426, United States
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New York New York, 10029, United States
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Asheville North Carolina, 28806, United States
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Durham North Carolina, 27710, United States
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Winston-Salem North Carolina, 27103, United States
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Bismarck North Dakota, 58501, United States
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Abington Pennsylvania, 19001, United States
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Sioux Falls South Dakota, 57104, United States
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Fort Sam Houston Texas, 78234, United States
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San Antonio Texas, 78229, United States
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Annandale Virginia, 22003, United States
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Green Bay Wisconsin, 54301, United States
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Milwaukee Wisconsin, 53215, United States
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West Allis Wisconsin, 53227, United States
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New Lambton Heights New South Wales, 2305, Australia
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Wahroonga New South Wales, 2076, Australia
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Auchenflower Queensland, 4066, Australia
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Greenslopes Queensland, 4120, Australia
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East Bentleigh 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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Graz , 8020, Austria
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Graz , 8036, Austria
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Innsbruck , 6020, Austria
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Linz , 4010, Austria
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Wien , 1090, Austria
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Wien , 1160, Austria
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Charleroi , 6000, Belgium
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Edegem , 2650, Belgium
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Gent , 9000, Belgium
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Ieper , 8900, Belgium
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Leuven , 3000, Belgium
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Libramont , 6800, Belgium
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Liège , 4000, Belgium
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Namur , 5000, Belgium
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London Ontario, N6A 4, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Herlev , 2730, Denmark
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København , 2100, Denmark
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Amiens , 80000, France
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Avignon cedex 9 , 84918, France
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Lyon cedex 8 , 69373, France
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Poitiers , 86021, France
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Saint Cloud , 92210, France
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Berlin , 13353, Germany
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Bonn , 53105, Germany
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Düsseldorf , 40217, Germany
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Erlangen , 91054, Germany
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Essen , 45136, Germany
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Frankfurt am Main , 60590, Germany
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Freiburg , 79106, Germany
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Hannover , 30177, Germany
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Marburg , 35043, Germany
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München , 81377, Germany
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München , 81675, Germany
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Rostock , 18059, Germany
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Tübingen , 72076, Germany
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Hong Kong , , Hong Kong
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New Territories , , Hong Kong
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Budapest , 1032, Hungary
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Budapest , 1062, Hungary
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Debrecen , 4032, Hungary
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Miskolc , 3526, Hungary
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Szeged , 6720, Hungary
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Zalaegerszeg - Pozva , 8900, Hungary
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Campobasso , 86100, Italy
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Genova , 16128, Italy
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Milano , 20133, Italy
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Milano , 20141, Italy
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Napoli , 80131, Italy
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Roma , 00128, Italy
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Roma , 00161, Italy
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Roma , 00168, Italy
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Grafton, Auckland , 1023, New Zealand
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Tauranga , 3143, New Zealand
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Bialystok , 15-02, Poland
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Gdansk , 80-21, Poland
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Singapore , 16961, Singapore
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Singapore , 22989, Singapore
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Bratislava , 812 5, Slovakia
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Bratislava , 831 0, Slovakia
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Kosice , 041 9, Slovakia
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Presov , 080 0, Slovakia
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Aarau , 5001, Switzerland
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Chur , 7000, Switzerland
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Geneva 14 , 1211, Switzerland
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Zurich , 8091, Switzerland
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Tainan , 70403, Taiwan
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Taipei , 10041, Taiwan
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Taipei , 10449, Taiwan
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London , NW1 2, United Kingdom
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London , SE1 9, United Kingdom
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London , SW3 6, United Kingdom
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Manchester , M20 4, United Kingdom
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Northwood , HA6 2, United Kingdom
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Nottingham , NG5 1, United Kingdom
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Poole , BH15 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

223

Study ID:

NCT01281254

Recruitment Status:

Terminated

Sponsor:


Amgen

How clear is this clinincal trial information?

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