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Studio di efficacia e sicurezza di NIS793 in combinazione con chemioterapia standard di cura (SOC) nell'adenocarcinoma duttale pancreatico metastatico di prima linea (mPDAC) - daNIS-2

27 aprile 2026 aggiornato da: Novartis Pharmaceuticals

Uno studio randomizzato, in doppio cieco, di fase III, che confronta NIS793 in combinazione con gemcitabina e Nab-paclitaxel rispetto a placebo (rispetto a) in combinazione con gemcitabina e Nab-paclitaxel per il trattamento di prima linea dell'adenocarcinoma duttale pancreatico metastatico (mPDAC) - daNIS-2

Lo scopo di questo studio è valutare l'efficacia e la sicurezza di NIS793 in combinazione con gemcitabina/nab-paclitaxel rispetto a gemcitabina/nab-paclitaxel e placebo nell'adenocarcinoma duttale pancreatico metastatico di prima linea (mPDAC).

Questo studio mira a esplorare se il blocco del Transforming Growth Factor β (TGFβ) in combinazione con gemcitabina/nab-paclitaxel può ridurre la fibrosi nel PDAC, ripristinare la chemio-sensibilità e infine portare a miglioramenti nella sopravvivenza globale (OS) e altri esiti clinicamente rilevanti.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Questo è uno studio randomizzato, in doppio cieco, multicentrico a due bracci, di fase III che si compone di due parti:

  • Parte run-in di sicurezza: verrà condotta una parte run-in di sicurezza in aperto per confermare la dose raccomandata di fase 3 (RP3D) di NIS793 in combinazione con gemcitabina e nab-paclitaxel. Verranno arruolati fino a circa 10 partecipanti a ciascun livello di dose per raggiungere almeno 6 partecipanti valutabili; tuttavia, se la dose iniziale non è raccomandata e viene testato un livello di dose inferiore, verranno arruolati altri 10 partecipanti. La decisione di aprire la parte randomizzata si baserà sulla conferma della dose e sulla sicurezza disponibile, sulla farmacocinetica pertinente e su altri dati rilevanti dalla parte di rodaggio
  • Parte randomizzata: i partecipanti iscritti saranno randomizzati ai due bracci di trattamento.

Il trattamento in studio sarà somministrato come ciclo di trattamento di 28 giorni. I partecipanti saranno trattati fino a tossicità inaccettabile, progressione della malattia secondo RECIST 1.1, revoca del consenso o qualsiasi altra condizione di interruzione del trattamento specificata nel protocollo.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

511

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Applicabile sia per il rodaggio di sicurezza che per la parte randomizzata

    • - Partecipanti di età ≥18 anni con mPDAC confermato istologicamente o citologicamente (basato sulla valutazione locale e secondo le linee guida locali) ammissibili al trattamento in prima linea e non suscettibili di intervento chirurgico potenzialmente curativo
    • Presenza di almeno una lesione misurabile valutata mediante tomografia computerizzata (TC) e/o risonanza magnetica per immagini (MRI) secondo RECIST 1.1
    • Performance Status dell'Eastern Cooperative Oncology Group (ECOG) 0-1
    • Adeguata funzionalità degli organi (valutata dal laboratorio centrale per l'idoneità)
    • I partecipanti devono essersi ripresi dalle tossicità correlate al trattamento delle precedenti terapie antitumorali al grado ≤ 1 (CTCAE v 5.0) al momento dello screening, ad eccezione dell'alopecia.

Principali criteri di esclusione:

  • Applicabile sia per il rodaggio di sicurezza che per la parte randomizzata

    • Precedente trattamento antitumorale sistemico per PDAC metastatico
    • Tumori pancreatici neuroendocrini, acinosi o insulari
    • - Partecipanti con stato noto di carcinoma pancreatico ad alta instabilità dei microsatelliti (MSI-H) o con deficit di riparazione (se lo stato non è già disponibile, il test non è richiesto allo screening).
    • - Il partecipante non si è ripreso da un intervento chirurgico importante eseguito prima dell'inizio del trattamento in studio o ha subito un intervento chirurgico importante entro 4 settimane prima dell'inizio del trattamento in studio.
    • Radioterapia o radioterapia cerebrale ≤ 4 settimane prima dell'inizio del trattamento in studio (radioterapia palliativa per lesioni ossee consentita > 2 settimane prima dell'inizio del trattamento in studio).
    • Funzione cardiaca compromessa o malattia cardiovascolare clinicamente significativa
    • Uso di fattori di crescita ematopoietici o supporto trasfusionale ≤ 2 settimane prima dell'inizio del trattamento in studio.
    • - Il partecipante ha condizioni che sono considerate ad alto rischio di sanguinamento del tratto gastrointestinale clinicamente significativo o qualsiasi altra condizione associata o storia di sanguinamento significativo.
    • Ferite gravi che non guariscono.
    • Donne incinte o che allattano
    • Donne in età fertile, a meno che non dispongano di utilizzare metodi contraccettivi altamente efficaci durante il trattamento e dopo aver interrotto i trattamenti in studio come indicato
    • Neuropatia periferica preesistente > grado 1 (CTCAE v5.0)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: NIS793
Concentrato per soluzione per infusione (liquido in fiala)
Droga: Nab-paclitaxel
Per formulazione approvata localmente
Droga: Gemcitabina
Per formulazione approvata localmente
Sperimentale: 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.
Droga: NIS793
Concentrato per soluzione per infusione (liquido in fiala)
Droga: Nab-paclitaxel
Per formulazione approvata localmente
Droga: Gemcitabina
Per formulazione approvata localmente
Droga: Placebo
Destrosio 5% in soluzione acquosa (D5W) per infusione
Comparatore 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.
Droga: Nab-paclitaxel
Per formulazione approvata localmente
Droga: Gemcitabina
Per formulazione approvata localmente
Droga: Placebo
Destrosio 5% in soluzione acquosa (D5W) per infusione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle (4 Weeks) of Treatment.
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Adverse Events (AEs)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Investigatori

  • Direttore dello studio: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 settembre 2021

Completamento primario (Effettivo)

13 agosto 2024

Completamento dello studio (Effettivo)

13 agosto 2024

Date di iscrizione allo studio

Primo inviato

21 giugno 2021

Primo inviato che soddisfa i criteri di controllo qualità

21 giugno 2021

Primo Inserito (Effettivo)

23 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Novartis si impegna a condividere con ricercatori esterni qualificati, l'accesso ai dati a livello di paziente e a supportare i documenti clinici degli studi idonei. Queste richieste vengono esaminate e approvate da un comitato di revisione indipendente sulla base del merito scientifico. Tutti i dati forniti sono resi anonimi per rispettare la privacy dei pazienti che hanno partecipato allo studio in linea con le leggi e i regolamenti applicabili.

Questa disponibilità dei dati dello studio è conforme ai criteri e al processo descritti su www.clinicalstudydatarequest.com

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

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Sedi

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