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    ΠœΠ΅ΠΆΠ΄ΡƒΠ½Π°Ρ€ΠΎΠ΄Π½Ρ‹ΠΉ ΠΌΡƒΠ·Ρ‹ΠΊΠ°Π»ΡŒΠ½Ρ‹ΠΉ конкурс Π² Ρ„ΠΎΡ€ΠΌΠΈΡ€ΠΎΠ²Π°Π½ΠΈΠΈ ΠΈΠΌΠΈΠ΄ΠΆΠ° страны провСдСния (Π½Π° ΠΏΡ€ΠΈΠΌΠ΅Ρ€Π΅ ЕвровидСния 2017)

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    Аннотация выпускной ΠΊΠ²Π°Π»ΠΈΡ„ΠΈΠΊΠ°Ρ†ΠΈΠΎΠ½Π½ΠΎΠΉ Ρ€Π°Π±ΠΎΡ‚Ρ‹ ΠžΡ€Π»ΠΎΠ² Никита Π‘Π΅Ρ€Π³Π΅Π΅Π²ΠΈΡ‡ Β«ΠœΠ•Π–Π”Π£ΠΠΠ ΠžΠ”ΠΠ«Π™ ΠœΠ£Π—Π«ΠšΠΠ›Π¬ΠΠ«Π™ КОНКУРБ Π’ Π€ΠžΠ ΠœΠ˜Π ΠžΠ’ΠΠΠ˜Π˜ Π˜ΠœΠ˜Π”Π–Π БВРАНЫ ΠŸΠ ΠžΠ’Π•Π”Π•ΠΠ˜Π― (НА ΠŸΠ Π˜ΠœΠ•Π Π• Π•Π’Π ΠžΠ’Π˜Π”Π•ΠΠ˜Π―-2017)Β» Н. Ρ€ΡƒΠΊ. - Π‘Ρ‹ΠΊΠΎΠ²Π° Π•Π»Π΅Π½Π° Π’Π»Π°Π΄ΠΈΠΌΠΈΡ€ΠΎΠ²Π½Π°, Π΄ΠΎΠΊΡ‚ΠΎΡ€ филологичСских Π½Π°ΡƒΠΊ, Π΄ΠΎΡ†Π΅Π½Ρ‚ ΠšΠ°Ρ„Π΅Π΄Ρ€Π° связСй с ΠΎΠ±Ρ‰Π΅ΡΡ‚Π²Π΅Π½Π½ΠΎΡΡ‚ΡŒΡŽ ΠžΡ‡Π½Π°Ρ Ρ„ΠΎΡ€ΠΌΠ° обучСния ΠΠΊΡ‚ΡƒΠ°Π»ΡŒΠ½ΠΎΡΡ‚ΡŒ: ΠΌΠ΅ΠΆΠ΄ΡƒΠ½Π°Ρ€ΠΎΠ΄Π½Ρ‹ΠΉ ΠΌΡƒΠ·Ρ‹ΠΊΠ°Π»ΡŒΠ½Ρ‹ΠΉ конкурс Π•Π²Ρ€ΠΎΠ²ΠΈΠ΄Π΅Π½ΠΈΠ΅ ΠΊΠ°ΠΊ самоС ΠΌΠ°ΡΡˆΡ‚Π°Π±Π½ΠΎΠ΅ рСгулярноС высокотСхнологичноС Ρ‚Π΅Π»Π΅Π²ΠΈΠ·ΠΈΠΎΠ½Π½ΠΎΠ΅ ΠΈ ΠΌΠ΅Π΄ΠΈΠ°-событиС, ΠΊΠΎΡ‚ΠΎΡ€ΠΎΠ΅ . Π• Π΅ΠΆΠ΅Π³ΠΎΠ΄Π½ΠΎ Π°ΠΊΡ†Π΅Π½Ρ‚ΠΈΡ€ΡƒΠ΅Ρ‚ Π²Π½ΠΈΠΌΠ°Π½ΠΈΠ΅ Π°ΡƒΠ΄ΠΈΡ‚ΠΎΡ€ΠΈΠΈ Π½Π° Π½Π°Ρ†ΠΈΠΎΠ½Π°Π»ΡŒΠ½ΠΎ-ΠΊΡƒΠ»ΡŒΡ‚ΡƒΡ€Π½Ρ‹Ρ… особСнностях страны-ΠΎΡ€Π³Π°Π½ΠΈΠ·Π°Ρ‚ΠΎΡ€Π° конкурса, Ρ„ΠΎΡ€ΠΌΠΈΡ€ΡƒΠ΅Ρ‚ Π·Π½Π°Ρ‡ΠΈΡ‚Π΅Π»ΡŒΠ½Ρ‹Π΅ туристичСскиС ΠΏΠΎΡ‚ΠΎΠΊΠΈ ΠΈ Ρ‚Π΅ΠΌ самым способствуСт Ρ„ΠΎΡ€ΠΌΠΈΡ€ΠΎΠ²Π°Π½ΠΈΡŽ ΠΈΠΌΠΈΠ΄ΠΆΠ° Ρ‚Π΅Ρ€Ρ€ΠΈΡ‚ΠΎΡ€ΠΈΠΈ. Π‘ΠΎΠ»Π΅Π΅ Ρ‚ΠΎΠ³ΠΎ, ΠΏΠΎΠ±Π΅Π΄Π° страны-участницы конкурса ЕвровидСния Π·Π°Ρ‡Π°ΡΡ‚ΡƒΡŽ ΠΎΡ‚Ρ€Π°ΠΆΠ°Π΅Ρ‚ ΠΈΠ΄Π΅ΠΎΠ»ΠΎΠ³ΠΎ-политичСский Π²Π΅ΠΊΡ‚ΠΎΡ€ Π•Π²Ρ€ΠΎΠΏΡ‹ ΠΈ ΠΏΠΎ сути Π΄Π΅Π»Π° выполняСт Ρ„ΡƒΠ½ΠΊΡ†ΠΈΡŽ политичСского PR страны-побСдитСля ΠΈ страны-хозяйки мСроприятия. Π‘Π»Π΅Π΄ΠΎΠ²Π°Ρ‚Π΅Π»ΡŒΠ½ΠΎ Π°Π½Π°Π»ΠΈΠ· ΠΈΡΠΏΠΎΠ»ΡŒΠ·ΡƒΠ΅ΠΌΡ‹Ρ… Π½Π° мСроприятии ΠΊΠΎΠΌΠΌΡƒΠ½ΠΈΠΊΠ°Ρ‚ΠΈΠ²Π½Ρ‹Ρ… Ρ‚Π΅Ρ…Π½ΠΎΠ»ΠΎΠ³ΠΈΠΉ являСтся Π°ΠΊΡ‚ΡƒΠ°Π»ΡŒΠ½Ρ‹ΠΌ ΠΈ вострСбованным для событийного ΠΈ ΡƒΡΡ‚Ρ€ΠΎΠΈΡ‚Π΅Π»ΡŒΠ½ΠΎΠ³ΠΎ PR ΠžΠ±ΡŠΠ΅ΠΊΡ‚ исслСдования: ΠΊΠΎΠΌΠΌΡƒΠ½ΠΈΠΊΠ°Ρ†ΠΈΠΎΠ½Π½Ρ‹Π΅ активности ΠΌΠ΅ΠΆΠ΄ΡƒΠ½Π°Ρ€ΠΎΠ΄Π½ΠΎΠ³ΠΎ ΠΌΡƒΠ·Ρ‹ΠΊΠ°Π»ΡŒΠ½ΠΎΠ³ΠΎ конкурса (Π½Π° ΠΏΡ€ΠΈΠΌΠ΅Ρ€Π΅ ЕвровидСния Π² КиСвС Π² 2017 Π³.). ΠŸΡ€Π΅Π΄ΠΌΠ΅Ρ‚ исслСдования: функция статусного PR-мСроприятия Π² Ρ„ΠΎΡ€ΠΌΠΈΡ€ΠΎΠ²Π°Π½ΠΈΠΈ ΠΈΠΌΠΈΠ΄ΠΆΠ° страны. ЦСль исслСдования: Π΄ΠΎΠΊΠ°Π·Π°Ρ‚ΡŒ, Ρ‡Ρ‚ΠΎ ΠΌΠ΅ΠΆΠ΄ΡƒΠ½Π°Ρ€ΠΎΠ΄Π½Ρ‹ΠΉ ΠΌΡƒΠ·Ρ‹ΠΊΠ°Π»ΡŒΠ½Ρ‹ΠΉ конкурс Π•Π²Ρ€ΠΎΠ²ΠΈΠ΄Π΅Π½ΠΈΠ΅ способствуСт Ρ„ΠΎΡ€ΠΌΠΈΡ€ΠΎΠ²Π°Π½ΠΈΡŽ ΠΈΠΌΠΈΠ΄ΠΆΠ° страны провСдСния. Π—Π°Π΄Π°Ρ‡ΠΈ исслСдования: Ρ€Π°Π·Ρ€Π°Π±ΠΎΡ‚Π°Ρ‚ΡŒ тСрминологичСский Π°ΠΏΠΏΠ°Ρ€Π°Ρ‚ исслСдования Π½Π° основС Π½Π°ΡƒΡ‡Π½ΠΎΠΉ Π»ΠΈΡ‚Π΅Ρ€Π°Ρ‚ΡƒΡ€Ρ‹ ΠΏΠΎ ΠΈΠΌΠΈΠ΄ΠΆΠΌΠ΅ΠΉΠΊΠΈΠ½Π³Ρƒ, Π±Ρ€Π΅Π½Π΄ΠΈΠ½Π³Ρƒ ΠΈ ΠΈΠ²Π΅Π½Ρ‚-ΠΌΠ΅Π½Π΅Π΄ΠΆΠΌΠ΅Π½Ρ‚Ρƒ; ΠΎΠΏΡ€Π΅Π΄Π΅Π»ΠΈΡ‚ΡŒ Π°ΠΊΡ‚ΡƒΠ°Π»ΡŒΠ½Ρ‹Π΅ ΠΊΠΎΠΌΠΌΡƒΠ½ΠΈΠΊΠ°Ρ†ΠΈΠΎΠ½Π½Ρ‹Π΅ Ρ‚Π΅Ρ…Π½ΠΎΠ»ΠΎΠ³ΠΈΠΈ, примСняСмыС Π² Ρ€Π°ΠΌΠΊΠ°Ρ… ΡΠΏΠ΅Ρ†ΠΈΠ°Π»ΡŒΠ½Ρ‹Ρ… событий для формирования ΠΈΠΌΠΈΠ΄ΠΆΠ° страны; ΠΎΠΏΠΈΡΠ°Ρ‚ΡŒ Ρ€ΠΎΠ»ΡŒ ЕвропСйского Π’Π΅Ρ‰Π°Ρ‚Π΅Π»ΡŒΠ½ΠΎΠ³ΠΎ Боюза ΠΊΠ°ΠΊ ΠΎΡ€Π³Π°Π½ΠΈΠ·Π°Ρ‚ΠΎΡ€Π° ЕвровидСния Π² Ρ„ΠΎΡ€ΠΌΠΈΡ€ΠΎΠ²Π°Π½ΠΈΠΈ ΠΈΠΌΠΈΠ΄ΠΆΠ° страны провСдСния конкурса; ΠΎΡ†Π΅Π½ΠΈΡ‚ΡŒ ΡΡ„Ρ„Π΅ΠΊΡ‚ΠΈΠ²Π½ΠΎΡΡ‚ΡŒ Ρ€Π΅Π°Π»ΠΈΠ·ΠΎΠ²Π°Π½Π½Ρ‹Ρ… ΠΊΠΎΠΌΠΌΡƒΠ½ΠΈΠΊΠ°Ρ‚ΠΈΠ²Π½Ρ‹Ρ… Ρ‚Π΅Ρ…Π½ΠΎΠ»ΠΎΠ³ΠΈΠΉ формирования ΠΈΠΌΠΈΠ΄ΠΆΠ° страны Π² Ρ€Π°ΠΌΠΊΠ°Ρ… ЕвровидСния; Π΄Π°Ρ‚ΡŒ Ρ€Π΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°Ρ†ΠΈΠΈ ΠΏΠΎ Ρ„ΠΎΡ€ΠΌΠΈΡ€ΠΎΠ²Π°Π½ΠΈΡŽ ΠΈΠΌΠΈΠ΄ΠΆΠ° страны с ΠΏΠΎΠΌΠΎΡ‰ΡŒΡŽ ЕвровидСния. ВСорСтичСская Π±Π°Π·Π°: Π½Π°ΡƒΡ‡Π½Ρ‹Π΅ Ρ‚Ρ€ΡƒΠ΄Ρ‹ Π•. Π‘Ρ‹ΠΊΠΎΠ²ΠΎΠΉ, Π”. Π“Π°Π²Ρ€Ρ‹, А. ΠŸΠ°Π½ΠΊΡ€ΡƒΡ…ΠΈΠ½Π°, Π‘. ДТСнСса, Π•. ΠšΠ°Π²Π΅Ρ€ΠΈΠ½ΠΎΠΉ, Π£. Π₯Π°Π»ΡŒΡ†Π±Π°ΡƒΡ€Π°, Π”ΠΆ. Π“ΠΎΠ»Π΄Π±Π»Π°Ρ‚Ρ‚Π° Π° Ρ‚Π°ΠΊΠΆΠ΅ Ρ‚Ρ€ΡƒΠ΄Ρ‹ Π”. Пассмана ΠΎ ΠΌΡƒΠ·Ρ‹ΠΊΠ°Π»ΡŒΠ½ΠΎΠΌ бизнСсС, П. Π”ΠΆΠΎΡ€Π΄Π°Π½Π° ΠΎ ΠΏΡ€ΠΎΠ΄Π²ΠΈΠΆΠ΅Π½ΠΈΠΈ ΠΈΠΌΠΈΠ΄ΠΆΠ° стран с ΠΏΠΎΠΌΠΎΡ‰ΡŒΡŽ ЕвровидСния ΠΈ Π΄Ρ€. ЭмпиричСская Π±Π°Π·Π°: PR-Π΄ΠΎΠΊΡƒΠΌΠ΅Π½Ρ‚Ρ‹, Ρ€Π°Π·ΠΌΠ΅Ρ‰Π΅Π½Π½Ρ‹Π΅ Π½Π° сайтС ЕвровидСния ΠΈ ЕвропСйского Π’Π΅Ρ‰Π°Ρ‚Π΅Π»ΡŒΠ½ΠΎΠ³ΠΎ Боюза; Π±ΠΎΠ»Π΅Π΅ ΠΏΠΎΠ»ΡƒΡ‚ΠΎΡ€Π° ΠΌΠΈΠ»Π»ΠΈΠΎΠ½Π° статСй ΠΎΠ± Π£ΠΊΡ€Π°ΠΈΠ½Π΅ Π² СвропСйских БМИ, Ρ€Π°Π·ΠΌΠ΅Ρ‰Π΅Π½Π½Ρ‹Π΅ Π² Π±Π°Π·Π΅ ΠΏΡ€ΠΎΠ΅ΠΊΡ‚Π° ΠΌΠΎΠ½ΠΈΡ‚ΠΎΡ€ΠΈΠ½Π³Π° ΠΌΠ΅ΠΆΠ΄ΡƒΠ½Π°Ρ€ΠΎΠ΄Π½ΠΎΠ³ΠΎ ΠΈΠΌΠΈΠ΄ΠΆΠ° Π£ΠΊΡ€Π°ΠΈΠ½Ρ‹ Β«OkoΒ»; Π΄Π°Π½Π½Ρ‹Π΅ Π±Π°Π·Ρ‹ ΠΌΠ°Ρ‚Π΅Ρ€ΠΈΠ°Π»ΠΎΠ² БМИ ΠΈ ΡΠΎΡ†ΠΈΠ°Π»ΡŒΠ½Ρ‹Ρ… ΠΌΠ΅Π΄ΠΈΠ° Factiva; Π΄Π°Π½Π½Ρ‹Π΅ Google.Analytics. ΠŸΡ€Π°ΠΊΡ‚ΠΈΡ‡Π΅ΡΠΊΠ°Ρ Π·Π½Π°Ρ‡ΠΈΠΌΠΎΡΡ‚ΡŒ: исслСдованиС Π΄ΠΎΠΊΠ°Π·Ρ‹Π²Π°Π΅Ρ‚, Ρ‡Ρ‚ΠΎ ΠΌΠ΅ΠΆΠ΄ΡƒΠ½Π°Ρ€ΠΎΠ΄Π½Ρ‹ΠΉ ΠΌΡƒΠ·Ρ‹ΠΊΠ°Π»ΡŒΠ½Ρ‹ΠΉ конкурс Π•Π²Ρ€ΠΎΠ²ΠΈΠ΄Π΅Π½ΠΈΠ΅ Ρ„ΠΎΡ€ΠΌΠΈΡ€ΡƒΠ΅Ρ‚ ΠΈΠΌΠΈΠ΄ΠΆ страны провСдСния нСзависимо ΠΎΡ‚ ΡƒΡΠΏΠ΅ΡˆΠ½ΠΎΡΡ‚ΠΈ использования ΠΊΠΎΠ½ΠΊΡ€Π΅Ρ‚Π½Ρ‹Ρ… Ρ‚Π΅Ρ…Π½ΠΎΠ»ΠΎΠ³ΠΈΠΉ формирования ΠΈΠΌΠΈΠ΄ΠΆΠ° страны. ВСзисы исслСдования Π±Ρ‹Π»ΠΈ Π°ΠΏΡ€ΠΎΠ±ΠΈΡ€ΠΎΠ²Π°Π½Ρ‹ Π½Π° ΠΌΠ΅ΠΆΠ΄ΡƒΠ½Π°Ρ€ΠΎΠ΄Π½ΠΎΠΌ Π½Π°ΡƒΡ‡Π½ΠΎΠΌ Ρ„ΠΎΡ€ΡƒΠΌΠ΅ «МСдиа Π² соврСмСнном ΠΌΠΈΡ€Π΅. 57-Π΅ ΠŸΠ΅Ρ‚Π΅Ρ€Π±ΡƒΡ€Π³ΡΠΊΠΈΠ΅ чтСния», ΠΎΠΏΡƒΠ±Π»ΠΈΠΊΠΎΠ²Π°Π½Ρ‹ Π² сборникС ΠΌΠ°Ρ‚Π΅Ρ€ΠΈΠ°Π»ΠΎΠ² статСй Ρ„ΠΎΡ€ΡƒΠΌΠ° ΠΈ ΠΈΠΌΠ΅ΡŽΡ‚ статус Π½Π°ΡƒΡ‡Π½ΠΎΠΉ ΡΡ‚Π°Ρ‚ΡŒΠΈ, Ρ€Π°Π·ΠΌΠ΅Ρ‰Π΅Π½Π½ΠΎΠΉ Π² Π±Π°Π·Π΅ РИНЦ. Π‘Ρ‚Ρ€ΡƒΠΊΡ‚ΡƒΡ€Π° Ρ€Π°Π±ΠΎΡ‚Ρ‹: Π Π°Π±ΠΎΡ‚Π° состоит ΠΈΠ· ввСдСния, 3 Π³Π»Π°Π²: «функция ΡΠΏΠ΅Ρ†ΠΈΠ°Π»ΡŒΠ½ΠΎΠ³ΠΎ события Π² Ρ„ΠΎΡ€ΠΌΠΈΡ€ΠΎΠ²Π°Π½ΠΈΠΈ ΠΈΠΌΠΈΠ΄ΠΆΠ° страны», Β«Π•Π²Ρ€ΠΎΠ²ΠΈΠ΄Π΅Π½ΠΈΠ΅ ΠΊΠ°ΠΊ ΡΠΏΠ΅Ρ†ΠΈΠ°Π»ΡŒΠ½ΠΎΠ΅ событиС ЕвропСйского Π’Π΅Ρ‰Π°Ρ‚Π΅Π»ΡŒΠ½ΠΎΠ³ΠΎ Боюза» ΠΈ Β«ΠΊΠΎΠΌΠΌΡƒΠ½ΠΈΠΊΠ°Ρ†ΠΈΠΎΠ½Π½Ρ‹ΠΉ ΠΏΠΎΡ‚Π΅Π½Ρ†ΠΈΠ°Π» ЕвровидСния ΠΊΠ°ΠΊ ΠΏΠ»ΠΎΡ‰Π°Π΄ΠΊΠΈ для формирования ΠΈΠΌΠΈΠ΄ΠΆΠ° страны», Π·Π°ΠΊΠ»ΡŽΡ‡Π΅Π½ΠΈΡ, списка использованной Π»ΠΈΡ‚Π΅Ρ€Π°Ρ‚ΡƒΡ€Ρ‹ ΠΈΠ· 67 ΠΏΠΎΠ·ΠΈΡ†ΠΈΠΉ ΠΈ 12 ΠΏΡ€ΠΈΠ»ΠΎΠΆΠ΅Π½ΠΈΠΉ. ΠžΠ±Ρ‰ΠΈΠΉ объСм 76 страниц.Abstract of graduating qualification thesis Mikita Arlou INTERNATIONAL MUSIC CONTEST IN HOST COUNTRY IMAGE FORMATION (ON THE EXAMPLE OF EUROVISION 2017) Supervisor associate professor Elena Bykova, doctor of philology Department of PR in business full-time study Relevance: the international music contest Eurovision as the most wide scale regular high tech TV and Media event which annually emphasizes audience attention on national cultural features of the host country, forms tourist flows which have huge influence on territorial image formation. Besides the win of a participating in the Eurovision country often shows the ideological and political European vector and in fact serves as political PR of the winning or host country. Consequently the analysis of applied communication technologies is relevant and in-demand for event PR. Research object: communication activities of international music contest (on the example of Eurovision in Kyiv in 2017). Research subject: function of status PR event in country image formation. The aim of research: to prove that international music contest Eurovision contributes host country image formation. The tasks of research: to develop research terminology based on scientific literature on image making, branding and event management; to define actual communication technologies applied in special PR events on country image formation; to describe European Broadcasting Union role in host country image formation; to appreciate effectiveness of applied communication technologies on host country image formation in Eurovision; to give recommendations for host country image formation with the help of Eurovision. Theoretical base: scientific works written by E. Bykova, D. Gavra, A. Pankrukhin, B. Jenes, E. Kaverina, U. Halcbaur, J. Goldblatt and D. PassmanΒ΄s works on music business and P. Jordan on county image building with the help of Eurovision, etc. The empirical base: PR documents from official Eurovision and European Broadcasting Union websites; more than 1.5 million articles on Ukraine in European media stored in the base of international Ukrainian image monitoring project Oko; content of the mass media and social media base Factiva; Google.Analytics data. Practical significance: the research proves that international music contest Eurovision is relevant for the host country image formation independently of the success level of applied country image formation communication technologies. Approbation: General positions of current thesis were aprobated on international scientific forum Media in modern world and were published at the collection of articles of the forum and have the status of a scientific article posted in the RINC database. Thesis structure: Research consists of introduction, 3 chapters: Special event function in country image formation, Eurovision as EBU special event and communication potential of Eurovision as a platform for image formation; conclusion, literature list from 67 positions and 12 attachments. The total volume is 76 pages

    A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas

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    BACKGROUND: Ontuxizumab, a humanized monoclonal antibody, targets endosialin (tumor endothelial marker 1 [TEM-1] or CD248), which is expressed on sarcoma cells and is believed to be involved in tumor angiogenesis. This is the first trial to evaluate ontuxizumab in patients with sarcoma. METHODS: Part 1 was an open-label, dose-finding, safety lead-in: 4, 6, or 8 mg/kg with gemcitabine and docetaxel (G/D; 900 mg/m(2) gemcitabine on days 1 and 8 and 75 mg/m(2) docetaxel on day 8). In part 2, patients were randomized in a double-blind fashion in 2:1 ratio to ontuxizumab (8 mg/kg) or a placebo with G/D. Randomization was stratified by 4 histological cohorts. RESULTS: In part 2 with 209 patients, no significant difference in progression-free survival between ontuxizumab plus G/D (4.3 months; 95% confidence interval [CI], 2.7-6.3 months) and the placebo plus G/D (5.6 months; 95% CI, 2.6-8.3 months) was observed (P = .67; hazard ratio [HR], 1.07; 95% CI, 0.77-1.49). Similarly, there was no significant difference in median overall survival between the 2 groups: 18.3 months for the ontuxizumab plus G/D group (95% CI, 16.2-21.1 months) and 21.1 months for the placebo plus G/D group (95% CI, 14.2 months to not reached; P = .32; HR, 1.23; 95% CI, 0.82-1.82). No significant differences between the treatment groups occurred for any efficacy parameter by sarcoma cohort. The combination of ontuxizumab plus G/D was generally well tolerated. CONCLUSIONS: Ontuxizumab plus G/D showed no enhanced activity over chemotherapy alone in soft-tissue sarcomas, whereas the safety profile of the combination was consistent with G/D alone

    A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas

    No full text
    BACKGROUND: Ontuxizumab, a humanized monoclonal antibody, targets endosialin (tumor endothelial marker 1 [TEM-1] or CD248), which is expressed on sarcoma cells and is believed to be involved in tumor angiogenesis. This is the first trial to evaluate ontuxizumab in patients with sarcoma. METHODS: Part 1 was an open-label, dose-finding, safety lead-in: 4, 6, or 8Β mg/kg with gemcitabine and docetaxel (G/D; 900Β mg/m2 gemcitabine on days 1 and 8 and 75Β mg/m2 docetaxel on day 8). In part 2, patients were randomized in a double-blind fashion in 2:1 ratio to ontuxizumab (8Β mg/kg) or a placebo with G/D. Randomization was stratified by 4 histological cohorts. RESULTS: In part 2 with 209 patients, no significant difference in progression-free survival between ontuxizumab plus G/D (4.3Β months; 95% confidence interval [CI], 2.7-6.3Β months) and the placebo plus G/D (5.6Β months; 95% CI, 2.6-8.3Β months) was observed (PΒ =Β .67; hazard ratio [HR], 1.07; 95% CI, 0.77-1.49). Similarly, there was no significant difference in median overall survival between the 2 groups: 18.3Β months for the ontuxizumab plus G/D group (95% CI, 16.2-21.1Β months) and 21.1Β months for the placebo plus G/D group (95% CI, 14.2Β months to not reached; PΒ =Β .32; HR, 1.23; 95% CI, 0.82-1.82). No significant differences between the treatment groups occurred for any efficacy parameter by sarcoma cohort. The combination of ontuxizumab plus G/D was generally well tolerated. CONCLUSIONS: Ontuxizumab plus G/D showed no enhanced activity over chemotherapy alone in soft-tissue sarcomas, whereas the safety profile of the combination was consistent with G/D alone.status: publishe
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