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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017946-30 | EudraCT Number | ||
| ENGOT-ov-6 | |||
| TRINOVA-2 | Other Identifier | Amgen, Inc | |
| 20060517 | Other Identifier | Amgen. Inc. |
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Closure of long term follow up (LTFU) and study earlier than previously outlined in the protocol as no beneficial information gained from continuing LTFU.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo plus PLD | Placebo Comparator | Arm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW) |
|
| AMG386 plus PLD | Experimental | Arm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG386 plus PLD | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications | Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| • To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival | weekly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90027 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27914241 | Background | 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. | |
| 37407274 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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|
| Placebo plus PLD | Drug | 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) |
|
| San Francisco |
| California |
| 94143 |
| United States |
| Research Site | Norwalk | Connecticut | 06856 | United States |
| Research Site | Stamford | Connecticut | 06902 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Evanston | Illinois | 60201 | United States |
| Research Site | Saint Louis Park | Minnesota | 55426 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | Asheville | North Carolina | 28806 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Bismarck | North Dakota | 58501 | United States |
| Research Site | Abington | Pennsylvania | 19001 | United States |
| Research Site | Sioux Falls | South Dakota | 57104 | United States |
| Research Site | Fort Sam Houston | Texas | 78234 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Annandale | Virginia | 22003 | United States |
| Research Site | Green Bay | Wisconsin | 54301 | United States |
| Research Site | Milwaukee | Wisconsin | 53215 | United States |
| Research Site | West Allis | Wisconsin | 53227 | United States |
| Research Site | New Lambton Heights | New South Wales | 2305 | Australia |
| Research Site | Wahroonga | New South Wales | 2076 | Australia |
| Research Site | Auchenflower | Queensland | 4066 | Australia |
| Research Site | Greenslopes | Queensland | 4120 | Australia |
| Research Site | East Bentleigh | Victoria | 3165 | Australia |
| Research Site | Footscray | Victoria | 3011 | Australia |
| Research Site | Malvern | Victoria | 3144 | Australia |
| Research Site | Parkville | Victoria | 3052 | Australia |
| Research Site | Graz | 8020 | Austria |
| Research Site | Graz | 8036 | Austria |
| Research Site | Innsbruck | 6020 | Austria |
| Research Site | Linz | 4010 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Vienna | 1160 | Austria |
| Research Site | Charleroi | 6000 | Belgium |
| Research Site | Edegem | 2650 | Belgium |
| Research Site | Ghent | 9000 | Belgium |
| Research Site | Ieper | 8900 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Libramont | 6800 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Namur | 5000 | Belgium |
| Research Site | London | Ontario | N6A 4L6 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Copenhagen | 2100 | Denmark |
| Research Site | Herlev | 2730 | Denmark |
| Research Site | Amiens | 80000 | France |
| Research Site | Avignon | 84918 | France |
| Research Site | Lyon | 69373 | France |
| Research Site | Poitiers | 86021 | France |
| Research Site | Saint-Cloud | 92210 | France |
| Research Site | Berlin | 13353 | Germany |
| Research Site | Bonn | 53105 | Germany |
| Research Site | Düsseldorf | 40217 | Germany |
| Research Site | Erlangen | 91054 | Germany |
| Research Site | Essen | 45136 | Germany |
| Research Site | Frankfurt am Main | 60590 | Germany |
| Research Site | Freiburg im Breisgau | 79106 | Germany |
| Research Site | Hanover | 30177 | Germany |
| Research Site | Marburg | 35043 | Germany |
| Research Site | München | 81377 | Germany |
| Research Site | München | 81675 | Germany |
| Research Site | Rostock | 18059 | Germany |
| Research Site | Tübingen | 72076 | Germany |
| Research Site | Hong Kong | Hong Kong |
| Research Site | New Territories | Hong Kong |
| Research Site | Budapest | 1032 | Hungary |
| Research Site | Budapest | 1062 | Hungary |
| Research Site | Debrecen | 4032 | Hungary |
| Research Site | Miskolc | 3526 | Hungary |
| Research Site | Szeged | 6720 | Hungary |
| Research Site | Zalaegerszeg - Pozva | 8900 | Hungary |
| Research Site | Campobasso | 86100 | Italy |
| Research Site | Genova | 16128 | Italy |
| Research Site | Milan | 20133 | Italy |
| Research Site | Milan | 20141 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Roma | 00128 | Italy |
| Research Site | Roma | 00161 | Italy |
| Research Site | Roma | 00168 | Italy |
| Research Site | Grafton, Auckland | 1023 | New Zealand |
| Research Site | Tauranga | 3143 | New Zealand |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Gdansk | 80-219 | Poland |
| Research Site | Singapore | 169610 | Singapore |
| Research Site | Singapore | 229899 | Singapore |
| Research Site | Bratislava | 812 50 | Slovakia |
| Research Site | Bratislava | 831 01 | Slovakia |
| Research Site | Košice | 041 91 | Slovakia |
| Research Site | Prešov | 080 01 | Slovakia |
| Research Site | Aarau | 5001 | Switzerland |
| Research Site | Chur | 7000 | Switzerland |
| Research Site | Geneva | 1211 | Switzerland |
| Research Site | Zurich | 8091 | Switzerland |
| Research Site | Tainan | 70403 | Taiwan |
| Research Site | Taipei | 10041 | Taiwan |
| Research Site | Taipei | 10449 | Taiwan |
| Research Site | London | NW1 2PG | United Kingdom |
| Research Site | London | SE1 9RT | United Kingdom |
| Research Site | London | SW3 6JJ | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Northwood | HA6 2RN | United Kingdom |
| Research Site | Nottingham | NG5 1PB | United Kingdom |
| Research Site | Poole | BH15 2JB | United Kingdom |
| Derived |
| 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. |
| 37185961 | Derived | 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. |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C551398 | trebananib |
| C041277 | 1-dodecylpyridoxal |
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