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Studie av effektivitet og sikkerhet for NIS793 i kombinasjon med standardbehandling (SOC) kjemoterapi ved førstelinjemetastatisk pankreatisk ductal adenokarsinom (mPDAC) - daNIS-2

27. april 2026 oppdatert av: Novartis Pharmaceuticals

En randomisert, dobbeltblind fase III-studie, som sammenligner NIS793 i kombinasjon med gemcitabin og nab-paklitaxel versus (vs.) placebo kombinert med gemcitabin og nab-paklitaksel for førstelinjebehandling av metastatisk pankreatisk duktal adenokarsinom (mPD2AC) -daNIS

Hensikten med denne studien er å evaluere effektiviteten og sikkerheten til NIS793 i kombinasjon med gemcitabin/nab-paclitaxel versus gemcitabin/nab-paclitaxel og placebo i førstelinje metastatisk pankreas duktalt adenokarsinom (mPDAC).

Denne studien tar sikte på å undersøke om blokade av Transforming Growth Factor β (TGFβ) i kombinasjon med gemcitabin/nab-paclitaxel kan redusere fibrose i PDAC, gjenopprette kjemosensitivitet og til slutt føre til forbedringer i total overlevelse (OS) og andre klinisk relevante utfall.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Dette er en randomisert, dobbeltblind, multisenter to-arm fase III studie som har to deler:

  • Sikkerhetsinnkjøringsdel: En åpen sikkerhetsinnkjøringsdel vil bli utført for å bekrefte anbefalt fase 3-dose (RP3D) på NIS793 i kombinasjon med gemcitabin og nab-paklitaksel. Opptil ca. 10 deltakere vil bli registrert på hvert dosenivå for å oppnå minst 6 evaluerbare deltakere; men hvis startdosen ikke anbefales og et lavere dosenivå testes, vil 10 ekstra deltakere bli registrert. Beslutningen om å åpne den randomiserte delen vil være basert på dosebekreftelse og tilgjengelig sikkerhet, relevant PK og andre relevante data fra innkjøringsdelen
  • Randomisert del: Påmeldte deltakere vil bli randomisert til de to behandlingsarmene.

Studiebehandlingen vil bli administrert som en 28-dagers behandlingssyklus. Deltakerne vil bli behandlet inntil uakseptabel toksisitet, sykdomsprogresjon i henhold til RECIST 1.1, tilbaketrekking av samtykke eller enhver annen tilstand ved behandlingsavbrudd spesifisert i protokollen.

Studietype

Intervensjonell

Registrering (Faktiske)

511

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Novartis Investigative Site
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Novartis Investigative Site
  • Belgia
      • Bonheiden, Belgia, 2820
        • Novartis Investigative Site
      • Brussels, Belgia, 1200
        • Novartis Investigative Site
      • Edegem, Belgia, 2650
        • Novartis Investigative Site
      • Leuven, Belgia, 3000
        • Novartis Investigative Site
  • Brasil
    • Federal District
      • Brasília, Federal District, Brasil, 70200-730
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brasil, 98700-000
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brasil, 90560-032
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, Brasil, 04014-002
        • Novartis Investigative Site
  • 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
  • Finland
      • Helsinki, Finland, 00290
        • Novartis Investigative Site
      • Tampere, Finland, FIN-33521
        • Novartis Investigative Site
  • Forente stater
    • Arkansas
      • Fayetteville, Arkansas, Forente stater, 72703
        • Highlands Oncology Group
    • California
      • Los Angeles, California, Forente stater, 90095
        • University of California LA
    • Florida
      • Orlando, Florida, Forente stater, 32804
        • AdventHealth
    • Indiana
      • Fort Wayne, Indiana, Forente stater, 46815
        • Fort Wayne Medical Oncology Hematology Inc
    • New York
      • New York, New York, Forente stater, 10016
        • Nyu Clinical Cancer Center
    • Texas
      • Dallas, Texas, Forente stater, 75204
        • US Oncology Research Dallas
      • Houston, Texas, Forente stater, 77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Seattle Cancer Care Alliance
  • 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
  • Hellas
      • Thessaloniki, Hellas, 540 07
        • Novartis Investigative Site
      • Thessaloniki, Hellas, 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
  • 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
  • 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
        • Novartis Investigative Site
      • Beijing, Kina, 100036
        • Novartis Investigative Site
      • Shanghai, Kina, 200032
        • Novartis Investigative Site
      • Shanghai, Kina, 200127
        • Novartis Investigative Site
      • Shanghai, Kina, 200433
        • Novartis Investigative Site
      • Shanghai, Kina, 200025
        • Novartis Investigative Site
      • 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
  • Nederland
      • Utrecht, Nederland, 3543 AZ
        • Novartis Investigative Site
  • Norge
      • Oslo, Norge, NO-0407
        • Novartis Investigative Site
    • Oslo
      • Nordbyhagen, Oslo, Norge, 1478
        • Novartis Investigative Site
  • Russland
      • Omsk, Russland, 644013
        • Novartis Investigative Site
      • Saint Petersburg, Russland, 196603
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 168583
        • Novartis Investigative Site
  • Slovakia
      • Banská Bystrica, Slovakia, 975 17
        • Novartis Investigative Site
      • Bratislava, Slovakia, 83310
        • Novartis Investigative Site
      • Košice, Slovakia, 041 91
        • Novartis Investigative Site
  • Spania
      • Barcelona, Spania, 08035
        • Novartis Investigative Site
      • Madrid, Spania, 28034
        • Novartis Investigative Site
      • Madrid, Spania, 28040
        • Novartis Investigative Site
      • Madrid, Spania, 28009
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Spania, 15706
        • Novartis Investigative Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spania, 08907
        • Novartis Investigative Site
  • Storbritannia
      • Cambridge, Storbritannia, CB2 0QQ
        • Novartis Investigative Site
      • Liverpool, Storbritannia, CH63 4JY
        • Novartis Investigative Site
      • London, Storbritannia, EC1A 7BE
        • Novartis Investigative Site
      • Oxford, Storbritannia, OX3 7LE
        • Novartis Investigative Site
    • Surrey
      • Sutton, Surrey, Storbritannia, SM2 5PT
        • Novartis Investigative Site
  • Sveits
      • Bellinzona, Sveits, 6500
        • Novartis Investigative Site
      • Geneva, Sveits, 1211
        • Novartis Investigative Site
      • Sankt Gallen, Sveits, 9007
        • Novartis Investigative Site
  • Sverige
      • Malmö, Sverige, SE-205 02
        • Novartis Investigative Site
      • Umeå, Sverige, 901 85
        • Novartis Investigative Site
  • Sør -Korea
      • Seoul, Sør -Korea, 03080
        • Novartis Investigative Site
      • Seoul, Sør -Korea, 05505
        • Novartis Investigative Site
      • Seoul, Sør -Korea, 06591
        • Novartis Investigative Site
  • Taiwan
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Novartis Investigative Site
  • Tsjekkia
      • Brno, Tsjekkia, 656 53
        • Novartis Investigative Site
      • Hradec Králové, Tsjekkia, 500 05
        • Novartis Investigative Site
      • Nový Jičín, Tsjekkia, 741 01
        • Novartis Investigative Site
      • Prague, Tsjekkia, 140 59
        • Novartis Investigative Site
  • Tyrkia (Türkiye)
      • Izmir, Tyrkia (Türkiye), 35100
        • Novartis Investigative Site
    • Kadikoy
      • Istanbul, Kadikoy, Tyrkia (Türkiye), 34722
        • Novartis Investigative Site
    • Sihhiye-Altindag
      • Ankara, Sihhiye-Altindag, Tyrkia (Türkiye), 06230
        • Novartis Investigative Site
    • Yuregir
      • Adana, Yuregir, Tyrkia (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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Gjelder både for sikkerhetsinnkjøring og randomisert del

    • Deltakere i alderen ≥18 år med histologisk eller cytologisk bekreftet (basert på lokal vurdering og i henhold til lokale retningslinjer) mPDAC kvalifisert for behandling i førstelinjeinnstillingen og ikke mottagelig for potensielt kurativ kirurgi
    • Tilstedeværelse av minst én målbar lesjon vurdert ved datastyrt tomografi (CT) og/eller magnetisk resonansavbildning (MRI) i henhold til RECIST 1.1
    • Eastern Cooperative Oncology Group (ECOG) ytelsesstatus 0-1
    • Tilstrekkelig organfunksjon (vurdert av sentrallaboratorium for kvalifisering)
    • Deltakerne må ha kommet seg etter behandlingsrelaterte toksisiteter fra tidligere kreftbehandlinger til grad ≤ 1 (CTCAE v 5.0) på tidspunktet for screening, bortsett fra alopecia.

Hovedekskluderingskriterier:

  • Gjelder både for sikkerhetsinnkjøring og randomisert del

    • Tidligere systemisk anti-kreftbehandling for metastatisk PDAC
    • Pankreas-nevroendokrine, acinar- eller holmesvulster
    • Deltakere med kjent status for mikrosatellitt-instabilitet-høy (MSI-H) eller mismatch reparasjonsdefekt bukspyttkjertelkreft (hvis status ikke allerede er tilgjengelig, er testing ikke nødvendig ved screening).
    • Deltakeren har ikke kommet seg etter en større operasjon utført før start av studiebehandling eller har hatt en større operasjon innen 4 uker før start av studiebehandling.
    • Strålebehandling eller hjernestrålebehandling ≤ 4 uker før start av studiebehandling (palliativ strålebehandling mot beinlesjoner tillatt > 2 uker før start av studiebehandling).
    • Nedsatt hjertefunksjon eller klinisk signifikant kardiovaskulær sykdom
    • Bruk av hematopoietiske vekstfaktorer eller transfusjonsstøtte ≤ 2 uker før start av studiebehandling.
    • Deltakeren har tilstander som anses å ha en høy risiko for klinisk signifikant blødning i mage-tarmkanalen eller enhver annen tilstand forbundet med eller historie med betydelig blødning.
    • Alvorlige ikke-helende sår.
    • Gravide eller ammende kvinner
    • Kvinner i fertil alder, med mindre de er villige til å bruke svært effektive prevensjonsmetoder under behandling og etter å ha stoppet studiebehandlinger som angitt
    • Eksisterende perifer nevropati > grad 1 (CTCAE v5.0)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: NIS793
Konsentrat til infusjonsvæske (væske i hetteglass)
Legemiddel: Nab-paklitaksel
Per lokalt godkjent formulering
Legemiddel: Gemcitabin
Per lokalt godkjent formulering
Eksperimentell: 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.
Legemiddel: NIS793
Konsentrat til infusjonsvæske (væske i hetteglass)
Legemiddel: Nab-paklitaksel
Per lokalt godkjent formulering
Legemiddel: Gemcitabin
Per lokalt godkjent formulering
Legemiddel: Placebo
Dekstrose 5 % i vann (D5W) infusjonsoppløsning
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.
Legemiddel: Nab-paklitaksel
Per lokalt godkjent formulering
Legemiddel: Gemcitabin
Per lokalt godkjent formulering
Legemiddel: Placebo
Dekstrose 5 % i vann (D5W) infusjonsoppløsning

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Etterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. september 2021

Primær fullføring (Faktiske)

13. august 2024

Studiet fullført (Faktiske)

13. august 2024

Datoer for studieregistrering

Først innsendt

21. juni 2021

Først innsendt som oppfylte QC-kriteriene

21. juni 2021

Først lagt ut (Faktiske)

23. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Novartis er forpliktet til å dele med kvalifiserte eksterne forskere, tilgang til data på pasientnivå og støttende kliniske dokumenter fra kvalifiserte studier. Disse forespørslene blir gjennomgått og godkjent av et uavhengig granskningspanel på grunnlag av vitenskapelig fortjeneste. Alle data som oppgis er anonymisert for å respektere personvernet til pasienter som har deltatt i forsøket i tråd med gjeldende lover og forskrifter.

Denne prøvedatatilgjengeligheten er i henhold til kriteriene og prosessen beskrevet på www.clinicalstudydatarequest.com

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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