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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TERMINATED
PHASE3
223 participants
INTERVENTIONAL
2011-04-18
2017-04-19
Brief Summary
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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.
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
DOUBLE
Study Groups
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Placebo plus PLD
Arm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
Placebo plus PLD
Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug.
PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
AMG386 plus PLD
Arm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
AMG386 plus PLD
AMG 386 is a first in class investigational anti angiogenic drug that provides potent and selective inhibition of angiopoietins. AMG 386 is designed to inhibit angiogenesis by sequestering Ang1 and Ang2, thereby preventing their interaction with the Tie2 receptor. Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
Interventions
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AMG386 plus PLD
AMG 386 is a first in class investigational anti angiogenic drug that provides potent and selective inhibition of angiopoietins. AMG 386 is designed to inhibit angiogenesis by sequestering Ang1 and Ang2, thereby preventing their interaction with the Tie2 receptor. Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
Placebo plus PLD
Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug.
PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
Eligibility Criteria
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Inclusion Criteria
* 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 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
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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Research Site
Los Angeles, California, United States
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San Francisco, California, United States
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Norwalk, Connecticut, United States
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Stamford, Connecticut, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Evanston, Illinois, United States
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Saint Louis Park, Minnesota, United States
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New York, New York, United States
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Asheville, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Abington, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Fort Sam Houston, Texas, United States
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San Antonio, Texas, United States
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Annandale, Virginia, United States
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Green Bay, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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West Allis, Wisconsin, United States
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New Lambton Heights, New South Wales, Australia
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Wahroonga, New South Wales, Australia
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Auchenflower, Queensland, Australia
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Greenslopes, Queensland, Australia
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East Bentleigh, 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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Graz, , Austria
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Charleroi, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Ieper, , Belgium
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Leuven, , Belgium
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Libramont, , Belgium
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Liège, , Belgium
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Namur, , Belgium
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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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Copenhagen, , Denmark
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Herlev, , Denmark
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Amiens, , France
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Avignon, , France
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Lyon, , France
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Poitiers, , France
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Saint-Cloud, , France
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Berlin, , Germany
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Bonn, , Germany
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Düsseldorf, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Hanover, , Germany
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Marburg, , Germany
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München, , Germany
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München, , Germany
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Rostock, , Germany
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Tübingen, , Germany
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Hong Kong, , Hong Kong
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New Territories, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Miskolc, , Hungary
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Szeged, , Hungary
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Zalaegerszeg - Pozva, , Hungary
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Campobasso, , 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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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Grafton, Auckland, , New Zealand
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Tauranga, , New Zealand
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Bialystok, , Poland
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Gdansk, , Poland
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Singapore, , Singapore
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Singapore, , Singapore
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Prešov, , Slovakia
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Aarau, , Switzerland
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Chur, , Switzerland
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Geneva, , Switzerland
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Zurich, , Switzerland
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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London, , United Kingdom
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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
Countries
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References
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Marth C, Vergote I, Scambia G, Oberaigner W, Clamp A, Berger R, Kurzeder C, Colombo N, Vuylsteke P, Lorusso D, Hall M, Renard V, Pignata S, Kristeleit R, Altintas S, Rustin G, Wenham RM, Mirza MR, Fong PC, Oza A, Monk BJ, Ma H, Vogl FD, Bach BA. ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer. Eur J Cancer. 2017 Jan;70:111-121. doi: 10.1016/j.ejca.2016.09.004. Epub 2016 Dec 1.
Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2009-017946-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ENGOT-ov-6
Identifier Type: -
Identifier Source: secondary_id
TRINOVA-2
Identifier Type: OTHER
Identifier Source: secondary_id
20060517
Identifier Type: OTHER
Identifier Source: secondary_id
20060517
Identifier Type: -
Identifier Source: org_study_id