Estudio de eficacia y seguridad de NIS793 en combinación con quimioterapia estándar de atención (SOC) en adenocarcinoma ductal pancreático metastásico de primera línea (mPDAC) - daNIS-2
27 de abril de 2026 actualizado por: Novartis Pharmaceuticals
Un estudio de fase III, aleatorizado, doble ciego, que compara NIS793 en combinación con gemcitabina y Nab-paclitaxel versus (vs.) Placebo combinado con gemcitabina y Nab-paclitaxel para el tratamiento de primera línea del adenocarcinoma ductal pancreático metastásico (mPDAC) - daNIS-2
El propósito de este estudio es evaluar la eficacia y la seguridad de NIS793 en combinación con gemcitabina/nab-paclitaxel versus gemcitabina/nab-paclitaxel y placebo en adenocarcinoma ductal pancreático metastásico (mPDAC) de primera línea.
Este estudio tiene como objetivo explorar si el bloqueo del factor de crecimiento transformante β (TGFβ) en combinación con gemcitabina/nab-paclitaxel puede reducir la fibrosis en PDAC, restaurar la quimiosensibilidad y, en última instancia, conducir a mejoras en la supervivencia general (SG) y otros resultados clínicamente relevantes.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Este es un estudio de fase III aleatorizado, doble ciego, multicéntrico, de dos brazos, que consta de dos partes:
- Parte preliminar de seguridad: se llevará a cabo una parte inicial de seguridad de etiqueta abierta para confirmar la dosis de fase 3 recomendada (RP3D) de NIS793 en combinación con gemcitabina y nab-paclitaxel. Se inscribirán hasta aproximadamente 10 participantes en cada nivel de dosis para lograr al menos 6 participantes evaluables; sin embargo, si no se recomienda la dosis inicial y se prueba un nivel de dosis más bajo, se inscribirán 10 participantes adicionales. La decisión de abrir la parte aleatoria se basará en la confirmación de la dosis y la seguridad disponible, PK relevante y otros datos relevantes de la parte preliminar
- Parte aleatoria: los participantes inscritos serán asignados aleatoriamente a los dos brazos de tratamiento.
El tratamiento del estudio se administrará como un ciclo de tratamiento de 28 días. Los participantes serán tratados hasta toxicidad inaceptable, progresión de la enfermedad según RECIST 1.1, retiro del consentimiento o cualquier otra condición de interrupción del tratamiento especificada en el protocolo.
Tipo de estudio
Intervencionista
Inscripción (Actual)
511
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 13353
- Novartis Investigative Site
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Bochum, Alemania, 44791
- Novartis Investigative Site
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Essen, Alemania, 45147
- Novartis Investigative Site
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Hamburg, Alemania, 20249
- Novartis Investigative Site
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Ulm, Alemania, 89081
- Novartis Investigative Site
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Hesse
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Frankfurt am Main, Hesse, Alemania, 60488
- Novartis Investigative Site
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Alemania, 06120
- Novartis Investigative Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- Novartis Investigative Site
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Western Australia
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Perth, Western Australia, Australia, 6009
- Novartis Investigative Site
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Federal District
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Brasília, Federal District, Brasil, 70200-730
- Novartis Investigative Site
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brasil, 98700-000
- Novartis Investigative Site
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Porto Alegre, Rio Grande do Sul, Brasil, 90560-032
- Novartis Investigative Site
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São Paulo
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São Paulo, São Paulo, Brasil, 04014-002
- Novartis Investigative Site
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Bonheiden, Bélgica, 2820
- Novartis Investigative Site
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Brussels, Bélgica, 1200
- Novartis Investigative Site
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Edegem, Bélgica, 2650
- Novartis Investigative Site
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Leuven, Bélgica, 3000
- Novartis Investigative Site
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Ontario
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Brampton, Ontario, Canadá, L6R 3J7
- Novartis Investigative Site
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Cambridge, Ontario, Canadá, N1R 3G2
- Novartis Investigative Site
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Toronto, Ontario, Canadá, M4N 3M5
- Novartis Investigative Site
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Brno, Chequia, 656 53
- Novartis Investigative Site
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Hradec Králové, Chequia, 500 05
- Novartis Investigative Site
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Nový Jičín, Chequia, 741 01
- Novartis Investigative Site
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Prague, Chequia, 140 59
- Novartis Investigative Site
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Seoul, Corea del Sur, 03080
- Novartis Investigative Site
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Seoul, Corea del Sur, 05505
- Novartis Investigative Site
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Seoul, Corea del Sur, 06591
- Novartis Investigative Site
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Banská Bystrica, Eslovaquia, 975 17
- Novartis Investigative Site
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Bratislava, Eslovaquia, 83310
- Novartis Investigative Site
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Košice, Eslovaquia, 041 91
- Novartis Investigative Site
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Barcelona, España, 08035
- Novartis Investigative Site
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Madrid, España, 28034
- Novartis Investigative Site
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Madrid, España, 28040
- Novartis Investigative Site
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Madrid, España, 28009
- Novartis Investigative Site
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A Coruna
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Santiago Compostela, A Coruna, España, 15706
- Novartis Investigative Site
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, España, 08907
- Novartis Investigative Site
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
- Highlands Oncology Group
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California
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Los Angeles, California, Estados Unidos, 90095
- University of California LA
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Florida
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Orlando, Florida, Estados Unidos, 32804
- AdventHealth
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46815
- Fort Wayne Medical Oncology Hematology Inc
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New York
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New York, New York, Estados Unidos, 10016
- Nyu Clinical Cancer Center
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Texas
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Dallas, Texas, Estados Unidos, 75204
- US Oncology Research Dallas
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Hospital
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Seattle Cancer Care Alliance
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Helsinki, Finlandia, 00290
- Novartis Investigative Site
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Tampere, Finlandia, FIN-33521
- Novartis Investigative Site
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Avignon, Francia, 84082
- Novartis Investigative Site
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Besançon, Francia, 25030
- Novartis Investigative Site
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Créteil, Francia, 94010
- Novartis Investigative Site
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Lyon 08, Francia, 69373
- Novartis Investigative Site
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Marseille, Francia, 13273
- Novartis Investigative Site
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Montpellier, Francia, 34295
- Novartis Investigative Site
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Nantes, Francia, 44093
- Novartis Investigative Site
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Paris, Francia, 75015
- Novartis Investigative Site
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Alpes Maritimes
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Nice, Alpes Maritimes, Francia, 06189
- Novartis Investigative Site
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Thessaloniki, Grecia, 540 07
- Novartis Investigative Site
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Thessaloniki, Grecia, 570 01
- Novartis Investigative Site
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Budapest, Hungría, H 1122
- Novartis Investigative Site
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Budapest, Hungría, H-1097
- Novartis Investigative Site
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Hajdu Bihar Megye
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Debrecen, Hajdu Bihar Megye, Hungría, 4032
- Novartis Investigative Site
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Jerusalem, Israel, 9112001
- Novartis Investigative Site
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Ramat Gan, Israel, 5265601
- Novartis Investigative Site
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Tel Aviv, Israel, 6423906
- Novartis Investigative Site
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FI
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Florence, FI, Italia, 50134
- Novartis Investigative Site
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MI
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Milan, MI, Italia, 20133
- Novartis Investigative Site
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Milan, MI, Italia, 20162
- Novartis Investigative Site
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VR
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Verona, VR, Italia, 37134
- Novartis Investigative Site
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Aichi-ken
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Nagoya, Aichi-ken, Japón, 4648681
- Novartis Investigative Site
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Chiba
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Kashiwa, Chiba, Japón, 277-8577
- Novartis Investigative Site
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Kanagawa
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Yokohama, Kanagawa, Japón, 241-8515
- Novartis Investigative Site
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Osaka
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Osaka, Osaka, Japón, 5418567
- Novartis Investigative Site
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Tokyo
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Chuo Ku, Tokyo, Japón, 1040045
- Novartis Investigative Site
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Koto Ku, Tokyo, Japón, 1358550
- Novartis Investigative Site
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Oslo, Noruega, NO-0407
- Novartis Investigative Site
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Oslo
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Nordbyhagen, Oslo, Noruega, 1478
- Novartis Investigative Site
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Utrecht, Países Bajos, 3543 AZ
- Novartis Investigative Site
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Beijing, Porcelana, 100730
- Novartis Investigative Site
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Beijing, Porcelana, 100021
- Novartis Investigative Site
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Beijing, Porcelana, 100036
- Novartis Investigative Site
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Shanghai, Porcelana, 200032
- Novartis Investigative Site
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Shanghai, Porcelana, 200127
- Novartis Investigative Site
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Shanghai, Porcelana, 200433
- Novartis Investigative Site
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Shanghai, Porcelana, 200025
- Novartis Investigative Site
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Tianjin, Porcelana, 300480
- Novartis Investigative Site
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510000
- Novartis Investigative Site
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150081
- Novartis Investigative Site
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210029
- Novartis Investigative Site
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Liaoning
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Dalian, Liaoning, Porcelana, 116001
- Novartis Investigative Site
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Shandong
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Jining, Shandong, Porcelana, 272000
- Novartis Investigative Site
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Shanxi
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Xian, Shanxi, Porcelana, 710061
- Novartis Investigative Site
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- Novartis Investigative Site
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310022
- Novartis Investigative Site
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Cambridge, Reino Unido, CB2 0QQ
- Novartis Investigative Site
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Liverpool, Reino Unido, CH63 4JY
- Novartis Investigative Site
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London, Reino Unido, EC1A 7BE
- Novartis Investigative Site
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Oxford, Reino Unido, OX3 7LE
- Novartis Investigative Site
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Surrey
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Sutton, Surrey, Reino Unido, SM2 5PT
- Novartis Investigative Site
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Omsk, Rusia, 644013
- Novartis Investigative Site
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Saint Petersburg, Rusia, 196603
- Novartis Investigative Site
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Singapore, Singapur, 168583
- Novartis Investigative Site
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Malmö, Suecia, SE-205 02
- Novartis Investigative Site
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Umeå, Suecia, 901 85
- Novartis Investigative Site
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Bellinzona, Suiza, 6500
- Novartis Investigative Site
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Geneva, Suiza, 1211
- Novartis Investigative Site
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Sankt Gallen, Suiza, 9007
- Novartis Investigative Site
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Taipei, Taiwán, 10002
- Novartis Investigative Site
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Taipei, Taiwán, 11217
- Novartis Investigative Site
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Taoyuan, Taiwán, 33305
- Novartis Investigative Site
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Izmir, Turquía (Türkiye), 35100
- Novartis Investigative Site
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Kadikoy
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Istanbul, Kadikoy, Turquía (Türkiye), 34722
- Novartis Investigative Site
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Sihhiye-Altindag
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Ankara, Sihhiye-Altindag, Turquía (Türkiye), 06230
- Novartis Investigative Site
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Yuregir
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Adana, Yuregir, Turquía (Türkiye), 01250
- Novartis Investigative Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
Aplicable tanto para el rodaje de seguridad como para la pieza aleatoria
- Participantes de ≥18 años de edad con mPDAC confirmado histológica o citológicamente (basado en la evaluación local y según las pautas locales) elegibles para tratamiento en el entorno de primera línea y no susceptibles de cirugía potencialmente curativa
- Presencia de al menos una lesión medible evaluada por Tomografía Computarizada (TC) y/o Resonancia Magnética (RM) según RECIST 1.1
- Estado de desempeño 0-1 del Grupo Oncológico Cooperativo del Este (ECOG)
- Función adecuada de los órganos (evaluada por el laboratorio central para determinar la elegibilidad)
- Los participantes deben haberse recuperado de las toxicidades relacionadas con el tratamiento de terapias anticancerígenas anteriores a un grado ≤ 1 (CTCAE v 5.0) en el momento de la selección, excepto la alopecia.
Principales Criterios de Exclusión:
Aplicable tanto para el rodaje de seguridad como para la pieza aleatoria
- Tratamiento anticancerígeno sistémico previo para PDAC metastásico
- Tumores pancreáticos neuroendocrinos, acinares o de los islotes
- Participantes con estado conocido de inestabilidad de microsatélites alta (MSI-H) o cáncer de páncreas deficiente en reparación de errores de emparejamiento (si el estado aún no está disponible, no se requieren pruebas en la selección).
- El participante no se ha recuperado de una cirugía mayor realizada antes del inicio del tratamiento del estudio o se ha sometido a una cirugía mayor dentro de las 4 semanas anteriores al inicio del tratamiento del estudio.
- Radioterapia o radioterapia cerebral ≤ 4 semanas antes del inicio del tratamiento del estudio (radioterapia paliativa para lesiones óseas permitida > 2 semanas antes del inicio del tratamiento del estudio).
- Deterioro de la función cardíaca o enfermedad cardiovascular clínicamente significativa
- Uso de factores de crecimiento hematopoyéticos o apoyo transfusional ≤ 2 semanas antes del inicio del tratamiento del estudio.
- El participante tiene condiciones que se consideran de alto riesgo de sangrado gastrointestinal clínicamente significativo o cualquier otra condición asociada o antecedentes de sangrado significativo.
- Heridas graves que no cicatrizan.
- Mujeres embarazadas o en período de lactancia
- Mujeres en edad fértil, a menos que estén dispuestas a usar métodos anticonceptivos altamente efectivos durante el tratamiento y después de suspender los tratamientos del estudio según lo indicado
- Neuropatía periférica preexistente > grado 1 (CTCAE v5.0)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Safety run-in part: NIS793 plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel :
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment. |
Concentrado para perfusión de solución (líquido en vial)
Por formulación aprobada localmente
Por formulación aprobada localmente
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Experimental: Randomized part (Arm A): NIS793 plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, gemcitabine and nab-paclitaxel:
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment. |
Concentrado para perfusión de solución (líquido en vial)
Por formulación aprobada localmente
Por formulación aprobada localmente
Dextrosa al 5% en agua (D5W) solución para perfusión
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Comparador de placebos: Randomized part (Arm B): Placebo plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of placebo, gemcitabine and nab-paclitaxel:
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment. |
Por formulación aprobada localmente
Por formulación aprobada localmente
Dextrosa al 5% en agua (D5W) solución para perfusión
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle (4 Weeks) of Treatment.
Periodo de tiempo: Up to 4 weeks
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A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle (i.e., 28 days or 4 weeks) of the treatment with NIS793 in combination with gemcitabine/nab-paclitaxel.
The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5 was used for all grading.
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Up to 4 weeks
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Randomized Part: Overall Survival (OS)
Periodo de tiempo: From randomization up to death, assessed up to approximately 34 months
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Overall Survival (OS) was defined as the time from date of randomization/start of treatment to date of death due to any cause.
If a patient was not known to have died, survival was censored at the date of last known date patient alive.
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From randomization up to death, assessed up to approximately 34 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With Adverse Events (AEs)
Periodo de tiempo: Up to approximately 32 months
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An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. Treatment emergent Adverse Event (TEAEs) in this study are events that started after the first dose of study treatment and until 30 days after last dose of SOC chemotherapies and up to 90 days after NIS793, whichever is later. |
Up to approximately 32 months
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Percentage of Participants With Dose Interruptions and Dose Reductions of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Up to approximately 32 months
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No dose reductions were allowed for NIS793 in the Randomized part and beyond the first 28 days period of the Safety Run-in part. Increasing the dosing interval from every 2 weeks (Q2W) to every 2 weeks (Q4W) was allowed. Dose interruption for NIS793 was permitted if adverse drug reaction was suspected to be related to NIS793. If NIS793 was interrupted or delayed for > 8 weeks due to toxicity that was suspected to be related to treatment, study treatment was permanently discontinued. |
Up to approximately 32 months
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Dose Intensity of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Up to approximately 32 months
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Dose intensity was computed as the ratio of actual cumulative dose received and actual duration of exposure.
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Up to approximately 32 months
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Progression-Free Survival (PFS)
Periodo de tiempo: From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 34 months
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Progression-Free Survival (PFS) was defined as the time from the enrollment (run-in part) or randomization (randomized part) to the date of the first documented disease progression based on local investigator assessment as per RECIST 1.1 or date of death due to any cause, whichever occurs first.
PFS was censored if no PFS event was observed before the analysis cut-off date.
The censoring date was the date of the last adequate tumor assessment prior to the analysis cut-off.
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From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 34 months
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Overall Response Rate (ORR)
Periodo de tiempo: Up to approximately 34 months
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Overall Response Rate (ORR) was defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) as per local review.
ORR was evaluated according to RECIST 1.1.
The BOR was determined from response assessments undertaken while on treatment.
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Up to approximately 34 months
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Disease Control Rate (DCR)
Periodo de tiempo: Up to approximately 34 months
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Disease Control Rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), or Stable Disease (SD) or Non-CR/Non-progressive disease as per local review.
DCR was evaluated according to RECIST 1.1.
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Up to approximately 34 months
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Duration of Response (DOR)
Periodo de tiempo: Up to approximately 34 months
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Duration of Response (DOR) was defined as the duration of time between the date of first documented response (CR or PR) and the date of first documented progression or death due to any cause.
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Up to approximately 34 months
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Time to Response (TTR)
Periodo de tiempo: From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 34 months
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Time to Response (TTR) was defined as the duration of time between the date of enrollment (run-in part) or randomization (randomized part) and the date of first documented response of either CR or PR as per local review, which was subsequently confirmed.
TTR was evaluated according to RECIST 1.1.
Participants without a confirmed CR or PR were censored at the time of PFS event (i.e., disease progression or death due to any cause) for participants with a PFS event (i.e., disease progression or death due to any cause), or at the date of the last adequate tumor assessment for participants without a PFS event.
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From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 34 months
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Safety run-in Part: Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycles 1 and 3 Day 15 (0 hour (pre-dose)), Cycles 2, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization.
Ctrough was listed and summarized using descriptive statistics.
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Cycles 1 and 3 Day 15 (0 hour (pre-dose)), Cycles 2, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
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Safety run-in Part: Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization.
Cmax was listed and summarized using descriptive statistics.
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Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
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Safety run-in Part: Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization.
Tmax was listed and summarized using descriptive statistics.
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Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
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Randomized Part (Chinese Participants With Intensive PK Sampling): Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1 and Cycle 6 Day 1: 0 hour (pre-dose). 1 cycle = 28 days.
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In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Ctrough was summarized using descriptive statistics.
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Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1 and Cycle 6 Day 1: 0 hour (pre-dose). 1 cycle = 28 days.
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Randomized Part (Chinese Participants With Intensive PK Sampling): Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
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In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Cmax was summarized using descriptive statistics.
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Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
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Randomized Part (Chinese Participants With Intensive PK Sampling): Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
|
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Tmax was summarized using descriptive statistics.
|
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
|
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Randomized Part (Chinese Participants With Intensive PK Sampling): Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycles 1 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
|
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization and AUClast was summarized using descriptive statistics.
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Cycles 1 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
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Randomized Part (Chinese Participants With Intensive PK Sampling): Area Under the Curve Calculated to the End of a Dosing Interval (Tau) at Steady-state (AUCtau) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycles 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
|
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants.
Venous whole blood samples were collected and AUCtau was summarized using descriptive statistics.
|
Cycles 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
|
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Randomized Part (Participants Without Intensive PK Sampling): Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycles 2, 3, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
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For participants without intensive PK sampling, venous whole blood samples were collected for activity-based pharmacokinetics characterization.
Ctrough was listed and summarized using descriptive statistics.
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Cycles 2, 3, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
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Randomized Part (Participants Without Intensive PK Sampling): Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
|
For Chinese participants without intensive PK sampling schedule and global participants in the randomized part, for which only sparse PK samples were collected for activity-based pharmacokinetics characterization, Cmax was listed and summarized using descriptive statistics.
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Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
|
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Randomized Part (Participants Without Intensive PK Sampling): Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Periodo de tiempo: Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
|
For Chinese participants without intensive PK sampling schedule and global participants in the randomized part, for which only sparse PK samples were collected for activity-based pharmacokinetics characterization, Tmax was listed and summarized using descriptive statistics.
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Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
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Randomized Part: Anti-drug Antibodies (ADA) Against NIS793 Prevalence at Baseline
Periodo de tiempo: Baseline
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Anti-drug antibodies (ADA) against NIS793 prevalence at baseline refers to the proportion of subjects who have developed antibodies against the drug NIS793 before starting treatment.
This is calculated by dividing the number of subjects with ADA-positive samples at baseline by the total number of subjects whose baseline samples were tested for ADA.
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Baseline
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Randomized Part: Anti-drug Antibodies (ADA) Against NIS793 Incidence on Treatment
Periodo de tiempo: From date of first study drug intake up to approximately 34 months
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Anti-drug antibodies (ADA) against NIS793 incidence on treatment refers to the proportion of participants who developed antibodies against the drug NIS793 during the treatment period. This can be categorized into two types:
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From date of first study drug intake up to approximately 34 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de septiembre de 2021
Finalización primaria (Actual)
13 de agosto de 2024
Finalización del estudio (Actual)
13 de agosto de 2024
Fechas de registro del estudio
Enviado por primera vez
21 de junio de 2021
Primero enviado que cumplió con los criterios de control de calidad
21 de junio de 2021
Publicado por primera vez (Actual)
23 de junio de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CNIS793B12301
- 2021-000591-10 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
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SÍ
Descripción del plan IPD
Novartis se compromete a compartir con investigadores externos calificados el acceso a datos a nivel de paciente y documentos clínicos de respaldo de estudios elegibles. Estas solicitudes son revisadas y aprobadas por un panel de revisión independiente sobre la base del mérito científico. Todos los datos proporcionados se anonimizan para respetar la privacidad de los pacientes que han participado en el ensayo de acuerdo con las leyes y regulaciones aplicables.
La disponibilidad de datos de este ensayo está de acuerdo con los criterios y el proceso descritos en www.clinicalstudydatarequest.com
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .