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Estudo da Eficácia e Segurança de NIS793 em Combinação com Quimioterapia Padrão de Tratamento (SOC) em Adenocarcinoma Ductal Pancreático Metastático de Primeira Linha (mPDAC) - daNIS-2

27 de abril de 2026 atualizado por: Novartis Pharmaceuticals

Um estudo randomizado, duplo-cego, de fase III, comparando NIS793 em combinação com gencitabina e Nab-paclitaxel versus (vs.) Placebo combinado com gencitabina e Nab-paclitaxel para tratamento de primeira linha de adenocarcinoma ductal pancreático metastático (mPDAC) - daNIS-2

O objetivo deste estudo é avaliar a eficácia e segurança de NIS793 em combinação com gencitabina/nab-paclitaxel versus gencitabina/nab-paclitaxel e placebo em adenocarcinoma ductal pancreático metastático de primeira linha (mPDAC).

Este estudo tem como objetivo explorar se o bloqueio do Fator de Crescimento Transformador β (TGFβ) em combinação com gencitabina/nab-paclitaxel pode reduzir a fibrose em PDAC, restaurar a quimio-sensibilidade e, finalmente, levar a melhorias na sobrevida global (OS) e outros resultados clinicamente relevantes.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Este é um estudo de fase III randomizado, duplo-cego, multicêntrico, de dois braços, que tem duas partes:

  • Parte de teste de segurança: Uma parte de teste de segurança aberta será conduzida para confirmar a dose recomendada de fase 3 (RP3D) de NIS793 em combinação com gencitabina e nab-paclitaxel. Até aproximadamente 10 participantes serão inscritos em cada nível de dose para atingir pelo menos 6 participantes avaliáveis; no entanto, se a dose inicial não for recomendada e um nível de dose mais baixo for testado, 10 participantes adicionais serão inscritos. A decisão de abrir a parte randomizada será baseada na confirmação da dose e segurança disponível, farmacocinética relevante e outros dados relevantes da parte de execução
  • Parte randomizada: Os participantes inscritos serão randomizados para os dois braços de tratamento.

O tratamento do estudo será administrado como um ciclo de tratamento de 28 dias. Os participantes serão tratados até toxicidade inaceitável, progressão da doença por RECIST 1.1, retirada do consentimento ou qualquer outra condição de descontinuação do tratamento especificada no protocolo.

Tipo de estudo

Intervencional

Inscrição (Real)

511

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 13353
        • Novartis Investigative Site
      • Bochum, Alemanha, 44791
        • Novartis Investigative Site
      • Essen, Alemanha, 45147
        • Novartis Investigative Site
      • Hamburg, Alemanha, 20249
        • Novartis Investigative Site
      • Ulm, Alemanha, 89081
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Alemanha, 60488
        • Novartis Investigative Site
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Alemanha, 06120
        • Novartis Investigative Site
  • Austrália
    • South Australia
      • Adelaide, South Australia, Austrália, 5000
        • Novartis Investigative Site
    • Western Australia
      • Perth, Western Australia, Austrália, 6009
        • Novartis Investigative Site
  • Brasil
    • Federal District
      • Brasília, Federal District, Brasil, 70200-730
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brasil, 98700-000
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brasil, 90560-032
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, Brasil, 04014-002
        • Novartis Investigative Site
  • Bélgica
      • Bonheiden, Bélgica, 2820
        • Novartis Investigative Site
      • Brussels, Bélgica, 1200
        • Novartis Investigative Site
      • Edegem, Bélgica, 2650
        • Novartis Investigative Site
      • Leuven, Bélgica, 3000
        • Novartis Investigative Site
  • Canadá
    • Ontario
      • Brampton, Ontario, Canadá, L6R 3J7
        • Novartis Investigative Site
      • Cambridge, Ontario, Canadá, N1R 3G2
        • Novartis Investigative Site
      • Toronto, Ontario, Canadá, M4N 3M5
        • Novartis Investigative Site
  • China
      • Beijing, China, 100730
        • Novartis Investigative Site
      • Beijing, China, 100021
        • Novartis Investigative Site
      • Beijing, China, 100036
        • Novartis Investigative Site
      • Shanghai, China, 200032
        • Novartis Investigative Site
      • Shanghai, China, 200127
        • Novartis Investigative Site
      • Shanghai, China, 200433
        • Novartis Investigative Site
      • Shanghai, China, 200025
        • Novartis Investigative Site
      • Tianjin, China, 300480
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Novartis Investigative Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Novartis Investigative Site
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Novartis Investigative Site
    • Shandong
      • Jining, Shandong, China, 272000
        • Novartis Investigative Site
    • Shanxi
      • Xian, Shanxi, China, 710061
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Novartis Investigative Site
  • Cingapura
      • Singapore, Cingapura, 168583
        • Novartis Investigative Site
  • Coréia do Sul
      • Seoul, Coréia do Sul, 03080
        • Novartis Investigative Site
      • Seoul, Coréia do Sul, 05505
        • Novartis Investigative Site
      • Seoul, Coréia do Sul, 06591
        • Novartis Investigative Site
  • Eslováquia
      • Banská Bystrica, Eslováquia, 975 17
        • Novartis Investigative Site
      • Bratislava, Eslováquia, 83310
        • Novartis Investigative Site
      • Košice, Eslováquia, 041 91
        • Novartis Investigative Site
  • Espanha
      • Barcelona, Espanha, 08035
        • Novartis Investigative Site
      • Madrid, Espanha, 28034
        • Novartis Investigative Site
      • Madrid, Espanha, 28040
        • Novartis Investigative Site
      • Madrid, Espanha, 28009
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Espanha, 15706
        • Novartis Investigative Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Espanha, 08907
        • Novartis Investigative Site
  • Estados Unidos
    • Arkansas
      • Fayetteville, Arkansas, Estados Unidos, 72703
        • Highlands Oncology Group
    • California
      • Los Angeles, California, Estados Unidos, 90095
        • University of California LA
    • Florida
      • Orlando, Florida, Estados Unidos, 32804
        • AdventHealth
    • Indiana
      • Fort Wayne, Indiana, Estados Unidos, 46815
        • Fort Wayne Medical Oncology Hematology Inc
    • New York
      • New York, New York, Estados Unidos, 10016
        • Nyu Clinical Cancer Center
    • Texas
      • Dallas, Texas, Estados Unidos, 75204
        • US Oncology Research Dallas
      • Houston, Texas, Estados Unidos, 77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, Estados Unidos, 98109
        • Seattle Cancer Care Alliance
  • Finlândia
      • Helsinki, Finlândia, 00290
        • Novartis Investigative Site
      • Tampere, Finlândia, FIN-33521
        • Novartis Investigative Site
  • França
      • Avignon, França, 84082
        • Novartis Investigative Site
      • Besançon, França, 25030
        • Novartis Investigative Site
      • Créteil, França, 94010
        • Novartis Investigative Site
      • Lyon 08, França, 69373
        • Novartis Investigative Site
      • Marseille, França, 13273
        • Novartis Investigative Site
      • Montpellier, França, 34295
        • Novartis Investigative Site
      • Nantes, França, 44093
        • Novartis Investigative Site
      • Paris, França, 75015
        • Novartis Investigative Site
    • Alpes Maritimes
      • Nice, Alpes Maritimes, França, 06189
        • Novartis Investigative Site
  • Grécia
      • Thessaloniki, Grécia, 540 07
        • Novartis Investigative Site
      • Thessaloniki, Grécia, 570 01
        • Novartis Investigative Site
  • Holanda
      • Utrecht, Holanda, 3543 AZ
        • Novartis Investigative Site
  • Hungria
      • Budapest, Hungria, H 1122
        • Novartis Investigative Site
      • Budapest, Hungria, H-1097
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungria, 4032
        • Novartis Investigative Site
  • Israel
      • Jerusalem, Israel, 9112001
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Novartis Investigative Site
  • Itália
    • FI
      • Florence, FI, Itália, 50134
        • Novartis Investigative Site
    • MI
      • Milan, MI, Itália, 20133
        • Novartis Investigative Site
      • Milan, MI, Itália, 20162
        • Novartis Investigative Site
    • VR
      • Verona, VR, Itália, 37134
        • Novartis Investigative Site
  • Japão
    • Aichi-ken
      • Nagoya, Aichi-ken, Japão, 4648681
        • Novartis Investigative Site
    • Chiba
      • Kashiwa, Chiba, Japão, 277-8577
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama, Kanagawa, Japão, 241-8515
        • Novartis Investigative Site
    • Osaka
      • Osaka, Osaka, Japão, 5418567
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Japão, 1040045
        • Novartis Investigative Site
      • Koto Ku, Tokyo, Japão, 1358550
        • Novartis Investigative Site
  • Noruega
      • Oslo, Noruega, NO-0407
        • Novartis Investigative Site
    • Oslo
      • Nordbyhagen, Oslo, Noruega, 1478
        • Novartis Investigative Site
  • Reino Unido
      • Cambridge, Reino Unido, CB2 0QQ
        • Novartis Investigative Site
      • Liverpool, Reino Unido, CH63 4JY
        • Novartis Investigative Site
      • London, Reino Unido, EC1A 7BE
        • Novartis Investigative Site
      • Oxford, Reino Unido, OX3 7LE
        • Novartis Investigative Site
    • Surrey
      • Sutton, Surrey, Reino Unido, SM2 5PT
        • Novartis Investigative Site
  • Rússia
      • Omsk, Rússia, 644013
        • Novartis Investigative Site
      • Saint Petersburg, Rússia, 196603
        • Novartis Investigative Site
  • Suécia
      • Malmö, Suécia, SE-205 02
        • Novartis Investigative Site
      • Umeå, Suécia, 901 85
        • Novartis Investigative Site
  • Suíça
      • Bellinzona, Suíça, 6500
        • Novartis Investigative Site
      • Geneva, Suíça, 1211
        • Novartis Investigative Site
      • Sankt Gallen, Suíça, 9007
        • Novartis Investigative Site
  • Taiwan
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Novartis Investigative Site
  • Tcheca
      • Brno, Tcheca, 656 53
        • Novartis Investigative Site
      • Hradec Králové, Tcheca, 500 05
        • Novartis Investigative Site
      • Nový Jičín, Tcheca, 741 01
        • Novartis Investigative Site
      • Prague, Tcheca, 140 59
        • Novartis Investigative Site
  • Turquia (Türkiye)
      • Izmir, Turquia (Türkiye), 35100
        • Novartis Investigative Site
    • Kadikoy
      • Istanbul, Kadikoy, Turquia (Türkiye), 34722
        • Novartis Investigative Site
    • Sihhiye-Altindag
      • Ankara, Sihhiye-Altindag, Turquia (Türkiye), 06230
        • Novartis Investigative Site
    • Yuregir
      • Adana, Yuregir, Turquia (Türkiye), 01250
        • Novartis Investigative Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Aplicável tanto para run-in de segurança quanto para peças aleatórias

    • Participantes com idade ≥18 anos com mPDAC confirmado histológica ou citologicamente (com base na avaliação local e de acordo com as diretrizes locais) elegíveis para tratamento no cenário de primeira linha e não passíveis de cirurgia potencialmente curativa
    • Presença de pelo menos uma lesão mensurável avaliada por Tomografia Computadorizada (TC) e/ou Ressonância Magnética (RM) de acordo com RECIST 1.1
    • Status de desempenho do Eastern Cooperative Oncology Group (ECOG) 0-1
    • Função de órgão adequada (avaliada pelo laboratório central para elegibilidade)
    • Os participantes devem ter se recuperado de toxicidades relacionadas ao tratamento de terapias anticancerígenas anteriores para grau ≤ 1 (CTCAE v 5.0) no momento da triagem, exceto alopecia.

Principais Critérios de Exclusão:

  • Aplicável tanto para run-in de segurança quanto para peças aleatórias

    • Tratamento anticancerígeno sistêmico anterior para PDAC metastático
    • Tumores pancreáticos neuroendócrinos, acinares ou das ilhotas
    • Participantes com status conhecido de alta instabilidade de microssatélites (MSI-H) ou câncer de pâncreas deficiente em reparo de incompatibilidade (se o status ainda não estiver disponível, o teste não é necessário na triagem).
    • O participante não se recuperou de uma grande cirurgia realizada antes do início do tratamento do estudo ou teve uma grande cirurgia dentro de 4 semanas antes do início do tratamento do estudo.
    • Radioterapia ou radioterapia cerebral ≤ 4 semanas antes do início do tratamento do estudo (radioterapia paliativa para lesões ósseas permitida > 2 semanas antes do início do tratamento do estudo).
    • Função cardíaca prejudicada ou doença cardiovascular clinicamente significativa
    • Uso de fatores de crescimento hematopoiéticos ou suporte de transfusão ≤ 2 semanas antes do início do tratamento do estudo.
    • O participante tem condições consideradas de alto risco de sangramento gastrointestinal clinicamente significativo ou qualquer outra condição associada ou história de sangramento significativo.
    • Feridas graves que não cicatrizam.
    • Mulheres grávidas ou amamentando
    • Mulheres com potencial para engravidar, a menos que estejam dispostas a usar métodos anticoncepcionais altamente eficazes durante o tratamento e após interromper os tratamentos do estudo conforme indicado
    • Neuropatia periférica pré-existente > grau 1 (CTCAE v5.0)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Safety run-in part: NIS793 plus (Gemcitabine and Nab-paclitaxel)

Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel :

  • NIS793 at 2100 mg (Days 1 and 15)
  • Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
  • Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)

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.
Medicamento: NIS793
Concentrado para infusão de solução (líquido em frasco)
Medicamento: Nab-paclitaxel
Por formulação aprovada localmente
Medicamento: Gemcitabina
Por formulação aprovada localmente
Experimental: Randomized part (Arm A): NIS793 plus (Gemcitabine and Nab-paclitaxel)

Participants received a combination of NIS793, gemcitabine and nab-paclitaxel:

  • NIS793 at 2100 mg (Days 1 and 15) assuming this was the confirmed RP3D in the safety run-in part or NIS793 at 2100 mg on Day 1 if dose level -1 was the confirmed RP3D in the safety run-in
  • Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
  • Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)

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.
Medicamento: NIS793
Concentrado para infusão de solução (líquido em frasco)
Medicamento: Nab-paclitaxel
Por formulação aprovada localmente
Medicamento: Gemcitabina
Por formulação aprovada localmente
Medicamento: Placebo
Dextrose 5% em água (D5W) solução para infusão
Comparador de Placebo: Randomized part (Arm B): Placebo plus (Gemcitabine and Nab-paclitaxel)

Participants received a combination of placebo, gemcitabine and nab-paclitaxel:

  • Placebo for NIS793 (Days 1 and 15)
  • Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
  • Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)

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.
Medicamento: Nab-paclitaxel
Por formulação aprovada localmente
Medicamento: Gemcitabina
Por formulação aprovada localmente
Medicamento: Placebo
Dextrose 5% em água (D5W) solução para infusão

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle (4 Weeks) of Treatment.
Prazo: Up to 4 weeks
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.
Up to 4 weeks
Randomized Part: Overall Survival (OS)
Prazo: From randomization up to death, assessed up to approximately 34 months
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.
From randomization up to death, assessed up to approximately 34 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Adverse Events (AEs)
Prazo: Up to approximately 32 months

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
Percentage of Participants With Dose Interruptions and Dose Reductions of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: Up to approximately 32 months

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
Dose Intensity of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: Up to approximately 32 months
Dose intensity was computed as the ratio of actual cumulative dose received and actual duration of exposure.
Up to approximately 32 months
Progression-Free Survival (PFS)
Prazo: From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 34 months
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.
From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 34 months
Overall Response Rate (ORR)
Prazo: Up to approximately 34 months
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.
Up to approximately 34 months
Disease Control Rate (DCR)
Prazo: Up to approximately 34 months
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.
Up to approximately 34 months
Duration of Response (DOR)
Prazo: Up to approximately 34 months
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.
Up to approximately 34 months
Time to Response (TTR)
Prazo: From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 34 months
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.
From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 34 months
Safety run-in Part: Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: 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.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Ctrough was listed and summarized using descriptive statistics.
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.
Safety run-in Part: Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was listed and summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Safety run-in Part: Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: 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.
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.
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.
Randomized Part (Chinese Participants With Intensive PK Sampling): Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: 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 Cmax was summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: 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.
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
Prazo: 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.
Cycles 1 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
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
Prazo: 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.
Randomized Part (Participants Without Intensive PK Sampling): Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: Cycles 2, 3, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
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.
Cycles 2, 3, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Randomized Part (Participants Without Intensive PK Sampling): Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: 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.
Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Randomized Part (Participants Without Intensive PK Sampling): Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Prazo: 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.
Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Randomized Part: Anti-drug Antibodies (ADA) Against NIS793 Prevalence at Baseline
Prazo: Baseline
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.
Baseline
Randomized Part: Anti-drug Antibodies (ADA) Against NIS793 Incidence on Treatment
Prazo: From date of first study drug intake up to approximately 34 months

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:

  1. Treatment-induced ADA positive: Participants who were ADA-negative at baseline but became ADA-positive after starting the treatment.
  2. Treatment-boosted ADA positive: Participants who were ADA-positive at baseline and showed a significant increase in ADA titer during the treatment.
From date of first study drug intake up to approximately 34 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Investigadores

  • Diretor de estudo: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

30 de setembro de 2021

Conclusão Primária (Real)

13 de agosto de 2024

Conclusão do estudo (Real)

13 de agosto de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

21 de junho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de junho de 2021

Primeira postagem (Real)

23 de junho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CNIS793B12301
  • 2021-000591-10 (Número EudraCT)

Plano para dados de participantes individuais (IPD)

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Descrição do plano IPD

A Novartis está comprometida em compartilhar com pesquisadores externos qualificados, acesso a dados em nível de paciente e documentos clínicos de suporte de estudos elegíveis. Essas solicitações são analisadas e aprovadas por um painel de revisão independente com base no mérito científico. Todos os dados fornecidos são anonimizados para respeitar a privacidade dos pacientes que participaram do estudo, de acordo com as leis e regulamentos aplicáveis.

A disponibilidade dos dados do estudo está de acordo com os critérios e processos descritos em www.clinicalstudydatarequest.com

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