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Studie av effektivitet och säkerhet för NIS793 i kombination med standardbehandling (SOC) kemoterapi vid första linjens metastaserande pankreatisk ductal adenokarcinom (mPDAC) - daNIS-2

27 april 2026 uppdaterad av: Novartis Pharmaceuticals

En randomiserad, dubbelblind, fas III-studie, som jämför NIS793 i kombination med gemcitabin och nab-paklitaxel kontra (vs.) placebo kombinerat med gemcitabin och nab-paklitaxel för första linjens behandling av metastaserande pankreatiskt duktalt adenokarcinom (mPD2AC) -daNIS

Syftet med denna studie är att utvärdera effektiviteten och säkerheten av NIS793 i kombination med gemcitabin/nab-paclitaxel kontra gemcitabin/nab-paclitaxel och placebo vid första linjens metastaserande pankreas duktalt adenokarcinom (mPDAC).

Denna studie syftar till att undersöka om blockad av Transforming Growth Factor β (TGFβ) i kombination med gemcitabin/nab-paclitaxel kan minska fibros i PDAC, återställa kemokänslighet och i slutändan leda till förbättringar av total överlevnad (OS) och andra kliniskt relevanta resultat.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Detta är en randomiserad, dubbelblind, multicenter tvåarmad fas III-studie som har två delar:

  • Säkerhetsinkörningsdel: En öppen säkerhetsinkörningsdel kommer att genomföras för att bekräfta rekommenderad fas 3-dos (RP3D) av NIS793 i kombination med gemcitabin och nab-paklitaxel. Upp till cirka 10 deltagare kommer att registreras vid varje dosnivå för att uppnå minst 6 utvärderbara deltagare; men om startdosen inte rekommenderas och en lägre dosnivå testas, kommer ytterligare 10 deltagare att registreras. Beslutet att öppna den randomiserade delen kommer att baseras på dosbekräftelse och tillgänglig säkerhet, relevant PK och annan relevant data från inkörningsdelen
  • Randomiserad del: Inskrivna deltagare kommer att randomiseras till de två behandlingsarmarna.

Studiebehandlingen kommer att administreras som en 28-dagars behandlingscykel. Deltagarna kommer att behandlas tills oacceptabel toxicitet, sjukdomsprogression enligt RECIST 1.1, återkallande av samtycke eller något annat tillstånd för avbrytande av behandlingen som anges i protokollet.

Studietyp

Interventionell

Inskrivning (Faktisk)

511

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Finland
      • Helsinki, Finland, 00290
        • Novartis Investigative Site
      • Tampere, Finland, FIN-33521
        • Novartis Investigative Site
  • Frankrike
      • Avignon, Frankrike, 84082
        • Novartis Investigative Site
      • Besançon, Frankrike, 25030
        • Novartis Investigative Site
      • Créteil, Frankrike, 94010
        • Novartis Investigative Site
      • Lyon 08, Frankrike, 69373
        • Novartis Investigative Site
      • Marseille, Frankrike, 13273
        • Novartis Investigative Site
      • Montpellier, Frankrike, 34295
        • Novartis Investigative Site
      • Nantes, Frankrike, 44093
        • Novartis Investigative Site
      • Paris, Frankrike, 75015
        • Novartis Investigative Site
    • Alpes Maritimes
      • Nice, Alpes Maritimes, Frankrike, 06189
        • Novartis Investigative Site
  • Förenta staterna
    • Arkansas
      • Fayetteville, Arkansas, Förenta staterna, 72703
        • Highlands Oncology Group
    • California
      • Los Angeles, California, Förenta staterna, 90095
        • University of California LA
    • Florida
      • Orlando, Florida, Förenta staterna, 32804
        • AdventHealth
    • Indiana
      • Fort Wayne, Indiana, Förenta staterna, 46815
        • Fort Wayne Medical Oncology Hematology Inc
    • New York
      • New York, New York, Förenta staterna, 10016
        • Nyu Clinical Cancer Center
    • Texas
      • Dallas, Texas, Förenta staterna, 75204
        • US Oncology Research Dallas
      • Houston, Texas, Förenta staterna, 77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84112
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, Förenta staterna, 98109
        • Seattle Cancer Care Alliance
  • Grekland
      • Thessaloniki, Grekland, 540 07
        • Novartis Investigative Site
      • Thessaloniki, Grekland, 570 01
        • 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
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  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4648681
        • Novartis Investigative Site
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
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    • 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
  • Kanada
    • Ontario
      • Brampton, Ontario, Kanada, L6R 3J7
        • Novartis Investigative Site
      • Cambridge, Ontario, Kanada, N1R 3G2
        • Novartis Investigative Site
      • Toronto, Ontario, Kanada, M4N 3M5
        • 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
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      • Shanghai, Kina, 200025
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      • Tianjin, Kina, 300480
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510000
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    • 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
  • Nederländerna
      • Utrecht, Nederländerna, 3543 AZ
        • Novartis Investigative Site
  • Norge
      • Oslo, Norge, NO-0407
        • Novartis Investigative Site
    • Oslo
      • Nordbyhagen, Oslo, Norge, 1478
        • Novartis Investigative Site
  • Ryssland
      • Omsk, Ryssland, 644013
        • Novartis Investigative Site
      • Saint Petersburg, Ryssland, 196603
        • Novartis Investigative Site
  • Schweiz
      • Bellinzona, Schweiz, 6500
        • Novartis Investigative Site
      • Geneva, Schweiz, 1211
        • Novartis Investigative Site
      • Sankt Gallen, Schweiz, 9007
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  • Singapore
      • Singapore, Singapore, 168583
        • Novartis Investigative Site
  • Slovakien
      • Banská Bystrica, Slovakien, 975 17
        • Novartis Investigative Site
      • Bratislava, Slovakien, 83310
        • Novartis Investigative Site
      • Košice, Slovakien, 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
  • Storbritannien
      • Cambridge, Storbritannien, CB2 0QQ
        • Novartis Investigative Site
      • Liverpool, Storbritannien, CH63 4JY
        • Novartis Investigative Site
      • London, Storbritannien, EC1A 7BE
        • Novartis Investigative Site
      • Oxford, Storbritannien, OX3 7LE
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    • Surrey
      • Sutton, Surrey, Storbritannien, SM2 5PT
        • 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
  • Tjeckien
      • Brno, Tjeckien, 656 53
        • Novartis Investigative Site
      • Hradec Králové, Tjeckien, 500 05
        • Novartis Investigative Site
      • Nový Jičín, Tjeckien, 741 01
        • Novartis Investigative Site
      • Prague, Tjeckien, 140 59
        • Novartis Investigative Site
  • Turkiet (Türkiye)
      • Izmir, Turkiet (Türkiye), 35100
        • Novartis Investigative Site
    • Kadikoy
      • Istanbul, Kadikoy, Turkiet (Türkiye), 34722
        • Novartis Investigative Site
    • Sihhiye-Altindag
      • Ankara, Sihhiye-Altindag, Turkiet (Türkiye), 06230
        • Novartis Investigative Site
    • Yuregir
      • Adana, Yuregir, Turkiet (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
  • Ungern
      • Budapest, Ungern, H 1122
        • Novartis Investigative Site
      • Budapest, Ungern, H-1097
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Ungern, 4032
        • Novartis Investigative Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Gäller både säkerhetsinkörning och randomiserad del

    • Deltagare i åldern ≥18 år med histologiskt eller cytologiskt bekräftad (baserat på lokal bedömning och enligt lokala riktlinjer) mPDAC kvalificerade för behandling i första linjen och inte mottagliga för potentiellt botande kirurgi
    • Förekomst av minst en mätbar lesion bedömd med datortomografi (CT) och/eller magnetisk resonanstomografi (MRT) enligt RECIST 1.1
    • Eastern Cooperative Oncology Group (ECOG) Prestandastatus 0-1
    • Tillräcklig organfunktion (bedöms av centrallaboratoriet för behörighet)
    • Deltagarna måste ha återhämtat sig från behandlingsrelaterade toxiciteter från tidigare anticancerterapier till grad ≤ 1 (CTCAE v 5.0) vid tidpunkten för screening, förutom alopeci.

Huvudsakliga uteslutningskriterier:

  • Gäller både säkerhetsinkörning och randomiserad del

    • Tidigare systemisk anti-cancerbehandling för metastaserande PDAC
    • Pankreatiska neuroendokrina, acinära eller ö-tumörer
    • Deltagare med känd status av mikrosatellit-instabilitet-hög (MSI-H) eller felmatchning reparationsbrist pankreascancer (om status inte redan är tillgänglig krävs inte testning vid screening).
    • Deltagaren har inte återhämtat sig från en större operation som utförts innan studiebehandlingen påbörjades eller har genomgått en större operation inom 4 veckor innan studiebehandlingen påbörjades.
    • Strålbehandling eller strålbehandling av hjärnan ≤ 4 veckor före start av studiebehandling (palliativ strålbehandling mot skelettskador tillåten > 2 veckor före start av studiebehandling).
    • Nedsatt hjärtfunktion eller kliniskt signifikant hjärt-kärlsjukdom
    • Användning av hematopoetiska tillväxtfaktorer eller transfusionsstöd ≤ 2 veckor före start av studiebehandling.
    • Deltagaren har tillstånd som anses ha en hög risk för kliniskt signifikant blödning i mag-tarmkanalen eller något annat tillstånd associerat med eller historia av betydande blödning.
    • Allvarliga sår som inte läker.
    • Gravida eller ammande kvinnor
    • Kvinnor i fertil ålder, såvida de inte är villiga att använda högeffektiva preventivmetoder under behandlingen och efter avslutad studiebehandling enligt indikation
    • Redan existerande perifer neuropati > grad 1 (CTCAE v5.0)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: NIS793
Koncentrat för lösningsinfusion (vätska i injektionsflaska)
Läkemedel: Nab-paklitaxel
Enligt lokalt godkänd formulering
Läkemedel: Gemcitabin
Enligt lokalt godkänd formulering
Experimentell: 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.
Läkemedel: NIS793
Koncentrat för lösningsinfusion (vätska i injektionsflaska)
Läkemedel: Nab-paklitaxel
Enligt lokalt godkänd formulering
Läkemedel: Gemcitabin
Enligt lokalt godkänd formulering
Läkemedel: Placebo
Dextros 5 % i vatten (D5W) infusionslösning
Placebo-jämförare: 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.
Läkemedel: Nab-paklitaxel
Enligt lokalt godkänd formulering
Läkemedel: Gemcitabin
Enligt lokalt godkänd formulering
Läkemedel: Placebo
Dextros 5 % i vatten (D5W) infusionslösning

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Adverse Events (AEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Utredare

  • Studierektor: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 september 2021

Primärt slutförande (Faktisk)

13 augusti 2024

Avslutad studie (Faktisk)

13 augusti 2024

Studieregistreringsdatum

Först inskickad

21 juni 2021

Först inskickad som uppfyllde QC-kriterierna

21 juni 2021

Första postat (Faktisk)

23 juni 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Novartis har åtagit sig att dela med kvalificerade externa forskare, tillgång till data på patientnivå och stödjande kliniska dokument från kvalificerade studier. Dessa förfrågningar granskas och godkänns av en oberoende granskningspanel på grundval av vetenskapliga meriter. All data som tillhandahålls är anonymiserad för att respektera integriteten för patienter som har deltagit i prövningen i enlighet med tillämpliga lagar och förordningar.

Tillgängligheten av denna testdata är enligt kriterierna och processen som beskrivs på www.clinicalstudydatarequest.com

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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