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Undersøgelse af effektivitet og sikkerhed af NIS793 i kombination med Standard of Care (SOC) kemoterapi i førstelinjemetastatisk pancreas ductal adenokarcinom (mPDAC) - daNIS-2

27. april 2026 opdateret af: Novartis Pharmaceuticals

Et randomiseret, dobbeltblindt fase III-studie, der sammenligner NIS793 i kombination med gemcitabin og nab-paclitaxel versus (vs.) placebo kombineret med gemcitabin og nab-paclitaxel til førstelinjebehandling af metastatisk pancreas ductal adenocarcinom (mPD2AC) -daNIS

Formålet med denne undersøgelse er at evaluere effektiviteten og sikkerheden af ​​NIS793 i kombination med gemcitabin/nab-paclitaxel versus gemcitabin/nab-paclitaxel og placebo i første-linje metastatisk pancreas duktalt adenokarcinom (mPDAC).

Denne undersøgelse har til formål at undersøge, om blokade af Transforming Growth Factor β (TGFβ) i kombination med gemcitabin/nab-paclitaxel kan reducere fibrose i PDAC, genoprette kemofølsomhed og i sidste ende føre til forbedringer i den samlede overlevelse (OS) og andre klinisk relevante resultater.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er en randomiseret, dobbeltblind, multicenter to-arm fase III undersøgelse, der har to dele:

  • Sikkerhedsindkøringsdel: En åben sikkerhedsindkøringsdel vil blive udført for at bekræfte anbefalet fase 3-dosis (RP3D) af NIS793 i kombination med gemcitabin og nab-paclitaxel. Op til cirka 10 deltagere vil blive tilmeldt hvert dosisniveau for at opnå mindst 6 evaluerbare deltagere; men hvis startdosis ikke anbefales, og et lavere dosisniveau testes, vil yderligere 10 deltagere blive tilmeldt. Beslutningen om at åbne den randomiserede del vil være baseret på dosisbekræftelse og tilgængelig sikkerhed, relevant PK og andre relevante data fra indkøringsdelen
  • Randomiseret del: Tilmeldte deltagere vil blive randomiseret til de to behandlingsarme.

Studiebehandlingen vil blive administreret som en 28-dages behandlingscyklus. Deltagerne vil blive behandlet indtil uacceptabel toksicitet, sygdomsprogression i henhold til RECIST 1.1, tilbagetrækning af samtykke eller enhver anden betingelse for behandlingsophør angivet i protokollen.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

511

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Gælder for både sikkerhedsindkøring og randomiseret del

    • Deltagere i alderen ≥18 år med histologisk eller cytologisk bekræftet (baseret på lokal vurdering og i henhold til lokale retningslinjer) mPDAC, der er kvalificeret til behandling i første linje og ikke modtagelige for potentielt helbredende kirurgi
    • Tilstedeværelse af mindst én målbar læsion vurderet ved computertomografi (CT) og/eller magnetisk resonansbilleddannelse (MRI) i henhold til RECIST 1.1
    • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
    • Tilstrækkelig organfunktion (vurderet af centrallaboratorium for berettigelse)
    • Deltagerne skal være kommet sig fra behandlingsrelaterede toksiciteter fra tidligere anticancerterapier til grad ≤ 1 (CTCAE v 5.0) på screeningstidspunktet, undtagen alopeci.

Vigtigste ekskluderingskriterier:

  • Gælder for både sikkerhedsindkøring og randomiseret del

    • Tidligere systemisk anti-cancer behandling for metastatisk PDAC
    • Pancreas neuroendokrine, acinære eller ø-tumorer
    • Deltagere med kendt status for mikrosatellit-instabilitet-høj (MSI-H) eller mismatch reparation-deficient pancreascancer (hvis status ikke allerede er tilgængelig, er testning ikke påkrævet ved screening).
    • Deltageren er ikke kommet sig efter en større operation udført før starten af ​​undersøgelsesbehandlingen eller har fået foretaget en større operation inden for 4 uger før starten af ​​undersøgelsesbehandlingen.
    • Strålebehandling eller hjernestrålebehandling ≤ 4 uger før start af undersøgelsesbehandling (palliativ strålebehandling til knoglelæsioner tilladt > 2 uger før start af undersøgelsesbehandling).
    • Nedsat hjertefunktion eller klinisk signifikant kardiovaskulær sygdom
    • Brug af hæmatopoietiske vækstfaktorer eller transfusionsstøtte ≤ 2 uger før start af undersøgelsesbehandling.
    • Deltageren har tilstande, der anses for at have en høj risiko for klinisk signifikant blødning fra mave-tarmkanalen eller enhver anden tilstand forbundet med eller historie med betydelig blødning.
    • Alvorlige ikke-helende sår.
    • Gravide eller ammende kvinder
    • Kvinder i den fødedygtige alder, medmindre de er villige til at bruge højeffektive præventionsmetoder under behandlingen og efter at have stoppet undersøgelsesbehandlinger som indiceret
    • Eksisterende perifer neuropati > grad 1 (CTCAE v5.0)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 793 NIS
Koncentrat til opløsningsinfusion (væske i hætteglas)
Medicin: Nab-paclitaxel
I henhold til lokalt godkendt formulering
Medicin: Gemcitabin
I henhold til lokalt godkendt formulering
Eksperimentel: 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.
Medicin: 793 NIS
Koncentrat til opløsningsinfusion (væske i hætteglas)
Medicin: Nab-paclitaxel
I henhold til lokalt godkendt formulering
Medicin: Gemcitabin
I henhold til lokalt godkendt formulering
Medicin: Placebo
Dextrose 5 % i vand (D5W) opløsning til infusion
Placebo komparator: 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.
Medicin: Nab-paclitaxel
I henhold til lokalt godkendt formulering
Medicin: Gemcitabin
I henhold til lokalt godkendt formulering
Medicin: Placebo
Dextrose 5 % i vand (D5W) opløsning til infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle (4 Weeks) of Treatment.
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Adverse Events (AEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. september 2021

Primær færdiggørelse (Faktiske)

13. august 2024

Studieafslutning (Faktiske)

13. august 2024

Datoer for studieregistrering

Først indsendt

21. juni 2021

Først indsendt, der opfyldte QC-kriterier

21. juni 2021

Først opslået (Faktiske)

23. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Novartis er forpligtet til at dele med kvalificerede eksterne forskere, adgang til data på patientniveau og understøttende kliniske dokumenter fra kvalificerede undersøgelser. Disse anmodninger gennemgås og godkendes af et uafhængigt bedømmelsespanel på grundlag af videnskabelig fortjeneste. Alle opgivne data er anonymiseret for at respektere privatlivets fred for patienter, der har deltaget i forsøget i overensstemmelse med gældende love og regler.

Tilgængeligheden af ​​denne forsøgsdata er i overensstemmelse med kriterierne og processen beskrevet på www.clinicalstudydatarequest.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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