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1차 전이성 췌관 선암종(mPDAC)에서 표준치료(SOC) 화학요법과 병용한 NIS793의 효능 및 안전성 연구 - daNIS-2

2026년 4월 27일 업데이트: Novartis Pharmaceuticals

전이성 췌관 선암종(mPDAC)의 1차 치료를 위해 NIS793과 젬시타빈 및 Nab-파클리탁셀을 병용한 것과 (vs.) 위약을 젬시타빈 및 Nab-파클리탁셀과 병용한 무작위 이중 맹검 III상 연구 - daNIS-2

이 연구의 목적은 1차 전이성 췌관 선암종(mPDAC)에서 젬시타빈/nab-파클리탁셀 및 위약과 비교하여 젬시타빈/nab-파클리탁셀과 병용한 NIS793의 효능 및 안전성을 평가하는 것입니다.

이 연구의 목적은 젬시타빈/nab-파클리탁셀과 조합된 TGFβ(Transforming Growth Factor β)의 차단이 PDAC의 섬유증을 감소시키고, 화학요법 감수성을 회복하고 궁극적으로 전체 생존(OS) 및 기타 임상적으로 관련된 결과의 개선으로 이어질 수 있는지 여부를 조사하는 것입니다.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

이것은 두 부분으로 구성된 무작위, 이중 맹검, 다기관 2군, 3상 연구입니다.

  • 안전성 시험단계(Safety run-in part): NIS793과 젬시타빈 및 냅-파클리탁셀 병용요법의 권장 3상 용량(RP3D)을 확인하기 위해 공개 라벨 안전성 시험단계를 실시할 예정이다. 최소 6명의 평가 가능한 참가자를 달성하기 위해 최대 약 10명의 참가자가 각 용량 수준에 등록됩니다. 그러나 시작 용량이 권장되지 않고 더 낮은 용량 수준이 테스트되는 경우 10명의 추가 참가자가 등록됩니다. 무작위 부분을 여는 결정은 용량 확인 및 사용 가능한 안전성, 관련 PK 및 도입 부분의 기타 관련 데이터를 기반으로 합니다.
  • 무작위 부분: 등록된 참가자는 두 치료 부문에 무작위 배정됩니다.

연구 치료제는 28일 치료 주기로 투여될 것입니다. 참가자는 허용할 수 없는 독성, RECIST 1.1에 따른 질병 진행, 동의 철회 또는 프로토콜에 지정된 기타 치료 중단 조건까지 치료를 받습니다.

연구 유형

중재적

등록 (실제)

511

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • Safety run-in 및 Randomized 부분 모두에 적용 가능

    • 조직학적 또는 세포학적으로 확인된 18세 이상의 참가자(현지 평가 및 현지 지침에 따름)
    • RECIST 1.1에 따라 전산화 단층촬영(CT) 및/또는 자기공명영상(MRI)으로 평가한 최소 하나의 측정 가능한 병변의 존재
    • 동부 협력 종양학 그룹(ECOG) 성과 상태 0-1
    • 적절한 장기 기능(적격성을 위해 중앙 실험실에서 평가)
    • 참가자는 탈모증을 제외하고 스크리닝 시점에 이전 항암 요법의 치료 관련 독성에서 등급 ≤ 1(CTCAE v 5.0)로 회복되어야 합니다.

주요 배제 기준:

  • Safety run-in 및 Randomized 부분 모두에 적용 가능

    • 전이성 PDAC에 대한 이전 전신 항암 치료
    • 췌장 신경내분비선, 세엽 또는 섬 종양
    • 현미부수체 불안정성 높음(MSI-H) 또는 불일치 복구 결함 췌장암 상태가 알려진 참가자(상태가 아직 이용 가능하지 않은 경우 스크리닝 시 검사가 필요하지 않음).
    • 참가자는 연구 치료 시작 전에 수행된 대수술에서 회복되지 않았거나 연구 치료 시작 전 4주 이내에 대수술을 받았습니다.
    • 연구 치료 시작 전 ≤ 4주 전에 방사선 요법 또는 뇌 방사선 요법(뼈 병변에 대한 완화적 방사선 요법은 연구 치료 시작 > 2주 전에 허용됨).
    • 심장 기능 장애 또는 임상적으로 유의한 심혈관 질환
    • 연구 치료 시작 전 ≤ 2주 전에 조혈 성장 인자 또는 수혈 지원 사용.
    • 참가자는 임상적으로 유의한 위장관 출혈의 위험이 높은 것으로 간주되는 상태 또는 중대한 출혈과 관련되거나 병력이 있는 기타 상태를 가지고 있습니다.
    • 치유되지 않는 심각한 상처.
    • 임산부 또는 모유 수유 중인 여성
    • 가임 여성, 치료 중 및 연구 치료를 중단한 후 매우 효과적인 피임 방법을 기꺼이 사용하지 않는 경우
    • 기존 말초 신경병증 > 1등급(CTCAE v5.0)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: NIS793
용액 주입을 위한 농축액(Liquid in Vial)
의약품: Nab-파클리탁셀
현지에서 승인된 제형에 따라
의약품: 젬시타빈
현지에서 승인된 제형에 따라
실험적: 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.
의약품: NIS793
용액 주입을 위한 농축액(Liquid in Vial)
의약품: Nab-파클리탁셀
현지에서 승인된 제형에 따라
의약품: 젬시타빈
현지에서 승인된 제형에 따라
의약품: 위약
주입용 덱스트로스 5% 수용액(D5W) 용액
위약 비교기: 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.
의약품: Nab-파클리탁셀
현지에서 승인된 제형에 따라
의약품: 젬시타빈
현지에서 승인된 제형에 따라
의약품: 위약
주입용 덱스트로스 5% 수용액(D5W) 용액

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle (4 Weeks) of Treatment.
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Adverse Events (AEs)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

수사관

  • 연구 책임자: Novartis Pharmaceuticals, Novartis Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 9월 30일

기본 완료 (실제)

2024년 8월 13일

연구 완료 (실제)

2024년 8월 13일

연구 등록 날짜

최초 제출

2021년 6월 21일

QC 기준을 충족하는 최초 제출

2021년 6월 21일

처음 게시됨 (실제)

2021년 6월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 27일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Novartis는 자격을 갖춘 외부 연구원과 공유하고, 환자 수준 데이터에 액세스하고, 적격 연구의 임상 문서를 지원하기 위해 최선을 다하고 있습니다. 이러한 요청은 과학적 가치를 바탕으로 독립적인 검토 패널에서 검토하고 승인합니다. 제공된 모든 데이터는 해당 법률 및 규정에 따라 시험에 참여한 환자의 개인 정보를 존중하기 위해 익명으로 처리됩니다.

이 시험 데이터 가용성은 www.clinicalstudydatarequest.com에 설명된 기준 및 프로세스에 따릅니다.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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