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En undersøgelse af Ramucirumab (LY3009806) versus placebo hos deltagere med hepatocellulært karcinom og forhøjet baseline alfa-fetoprotein (REACH-2)

22. december 2022 opdateret af: Eli Lilly and Company

Randomiseret, dobbeltblindet, placebokontrolleret, fase 3-studie af Ramucirumab og Best Supportive Care (BSC) versus placebo og BSC som andenlinjebehandling hos patienter med hepatocellulært karcinom og forhøjet baseline alfa-fetoprotein (AFP) efter førstelinjebehandling Med Sorafenib

Formålet med denne undersøgelse er at evaluere sikkerheden og effektiviteten af ​​ramucirumab hos deltagere med hepatocellulært karcinom (HCC) og forhøjet baseline alfa-føtoprotein. Deltagerne vil blive randomiseret til ramucirumab eller placebo i et forhold på 2:1 (Main Global Cohort og China Maximized Extended Enrollment [MEE] Cohort). Deltagere kan også modtage ramucirumab, hvis de er kvalificerede til at blive tilmeldt Open-Label Expansion (OLE) Cohort.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

399

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Kurralta Park, Australien, 5037
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      • Woodville, Australien, 5011
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  • Belgien
      • Brussels, Belgien, 1200
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      • Liege, Belgien, 4000
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  • Brasilien
      • Barretos, Brasilien, 14784-400
        • Fundação Pio XII
      • Barretos, Brasilien, 14784700
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      • Belo Horizonte, Brasilien, 30130-090
        • Cenantron - Centro Avancado de Tratamento Oncologico
      • Ijui, Brasilien, 98700 000
        • Associação Hospital de Caridade Ijuí
      • Porto Alegre, Brasilien, 90470-340
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      • São Paulo, Brasilien, 04039-901
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  • Canada
      • Montreal, Canada, H2X 3E4
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      • Toronto, Canada, M5G 2M9
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  • Det Forenede Kongerige
      • Acton, Det Forenede Kongerige, W12 0HS
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      • Acton, Det Forenede Kongerige, w120hs
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      • Bebington, Det Forenede Kongerige, CH63 4JY
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      • Birmingham, Det Forenede Kongerige, B15 2TH
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      • London, Det Forenede Kongerige, SE5 9RS
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      • London, Det Forenede Kongerige, NW3 2QG
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      • Manchester, Det Forenede Kongerige, M20 4BX
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  • Forenede Stater
    • California
      • Daly City, California, Forenede Stater, 94115
        • Pacific Hematology and Oncology Associates
      • Los Angeles, California, Forenede Stater, 90024
        • UCLA Medical Center
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Georgetown University Medical Center
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
  • Frankrig
      • Amiens, Frankrig, 80054
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      • Avignon, Frankrig, 84918
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      • Besancon, Frankrig, 25030
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      • Caen, Frankrig, 14033
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      • Clermont-Ferrand, Frankrig, 63003
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      • Lyon, Frankrig, 69317
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      • Montpellier, Frankrig, 34295
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      • Nantes, Frankrig, 44093
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      • Pessac, Frankrig, 33604
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      • Rennes, Frankrig, 35042
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      • Saint Etienne, Frankrig, 42000
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  • Hong Kong
      • Hong Kong, Hong Kong
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      • Hong Kong, Hong Kong
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      • Kowloon, Hong Kong
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      • ShaTin, Hong Kong
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      • Tuen Mun, Hong Kong
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  • Israel
      • Haifa, Israel, 3109601
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      • Tel Aviv, Israel, 6423906
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  • Italien
      • Benevento, Italien, 82100
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      • Bologna, Italien, 40138
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      • Cremona, Italien, 26100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Padova, Italien, 35128
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      • Rome, Italien, 00168
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  • Japan
      • Chuo Ku, Japan, 104-0045
        • "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
      • Fukuoka, Japan, 810-8563
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      • Fukuoka, Japan, 811-1395
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      • Iizuka, Japan, 820-8505
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      • Kanazawa, Japan, 920-8641
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      • Kashiwa, Japan, 277 8577
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      • Kyoto, Japan, 606-8507
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      • Matsuyama, Japan, 791-0280
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      • Osaka, Japan, 589-8511
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      • Shimotsuke, Japan, 329-0498
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      • Suita-shi, Japan, 565-0871
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      • Sunto-Gun, Japan, 411-8777
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      • Tokyo, Japan, 101-0062
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      • Yokohama, Japan, 241-8515
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      • Ōsaka, Japan, 541-8567
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  • Kina
      • Beijing, Kina
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      • Beijing, Kina, 100032
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      • Beijing, Kina, 100142
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      • Beijing, Kina
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      • Changsha, Kina, 410011
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      • Changsha, Kina, 410013
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      • Chongqing, Kina, 400038
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      • Guangdong, Kina, 510515
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      • Guangzhou, Kina, 510080
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      • Hangzhou, Kina, 310003
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      • Hangzhou, Kina, 310009
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      • Hangzhou, Kina, 310022
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      • Hebei, Kina, 050011
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      • Hefei, Kina, 230022
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      • Heilongjiang, Kina, 150081
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      • Henan, Kina, 450008
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      • Hubei, Kina, 56456
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      • Nanjing, Kina, 210006
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      • Nanjing, Kina, 210002
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      • Nanning, Kina, 530021
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      • Qingdao, Kina, 266003
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      • Shanghai, Kina
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      • Shanghai, Kina, 200030
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      • Shanghai, Kina, 200127
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      • Shanghai, Kina
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      • Shenyang, Kina, 100042
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      • Wu Han, Kina, 430030
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      • Xi'an, Kina, 710032
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  • Korea, Republikken
      • Incheon, Korea, Republikken, 21565
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      • Seoul, Korea, Republikken, 06351
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      • Seoul, Korea, Republikken, 03080
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      • Seoul, Korea, Republikken, 05505
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul, Korea, Republikken, 03722
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Ulsan, Korea, Republikken, 44033
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Polen
      • Gdansk, Polen, 80-219
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Poznan, Polen, 61-866
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Warszawa, Polen, 01-748
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Schweiz
      • Bern, Schweiz, 3010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Spanien
      • Girona, Spanien, 17007
        • Hospital Universitari de Girona Dr. Josep Trueta
      • Madrid, Spanien, 28040
        • Hospital Clinico San Carlos
      • Santander, Spanien, 39008
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valencia, Spanien, 46026
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Taiwan
      • Kaohsiung city, Taiwan, 83301
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Puzi City, Taiwan, 61363
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taichung, Taiwan, 40705
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tainan, Taiwan, 704
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tainan, Taiwan, 71004
        • "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
      • Tainan, Taiwan, 736
        • "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
      • Taipei city, Taiwan, 10048
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taipei city, Taiwan, 11217
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Taoyuan City, Taiwan, 33305
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Tjekkiet
      • Brno, Tjekkiet, 656 53
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Praha 5, Tjekkiet, 150 06
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Tyskland
      • Bayern, Tyskland, 81377
        • "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
      • Berlin, Tyskland, 13125
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Essen, Tyskland, 45122
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Frankfurt, Tyskland, 60590
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hamburg, Tyskland, 20246
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hannover, Tyskland, 30625
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Leipzig, Tyskland, 04103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Magdeburg, Tyskland, 39120
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mainz, Tyskland, 55131
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • München, Tyskland, 81675
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tubingen, Tyskland, 72076
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Østrig
      • Linz, Østrig, 4020
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wien, Østrig, 1090
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Deltagelseskriterier

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

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

  • En diagnose af HCC baseret på histopatologiske fund eller en diagnose af skrumpelever og en tumor med klassiske HCC-billeddannelseskarakteristika.
  • Sorafenib var den eneste systemiske behandling for HCC og blev seponeret på grund af sygdomsprogression eller intolerance (kun de vigtigste globale og MEE-kohorter).
  • Deltageren modtog ≤2 tidligere systemisk behandlingsregime, eksklusive tidligere sorafenib eller kemoterapi, til behandling af HCC (kun OLE-kohorte).
  • ≥1 målbar læsion pr. responsevalueringskriterier i solide tumorer (RECIST) version 1.1, som ikke tidligere er blevet behandlet med lokoregional terapi. En deltager med en(e) læsion(er), der tidligere er behandlet med lokoregional terapi, er også berettiget, hvis læsionen har dokumenteret progression efter lokoregional behandling og er målbar.
  • Child-Pugh score <7 (Child-Pugh klasse A).
  • Barcelona Clinic Liver Cancer (BCLC) Stadie C sygdom eller BCLC Stadie B sygdom, der ikke er modtagelig for lokoregional terapi eller refraktær over for lokoregional terapi.
  • Baseline AFP ≥400 nanogram/milliliter.
  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 0 eller 1.
  • Opløsning af alle klinisk signifikante toksiske virkninger af tidligere behandling.
  • Total bilirubin ≤1,5 ​​gange øvre grænse for normal værdi (ULN), aspartattransaminase (AST) og alanintransaminase (ALT) ≤5 × ULN.
  • Kreatininclearance ≥60 milliliter/minut.
  • Urinprotein er ≤1+ på målepind eller rutinemæssig urinanalyse eller 24-timers urin, der viser <1 gram protein.
  • Absolut neutrofiltal ≥1,0 ​​× 10^9/liter, hæmoglobin ≥9 gram/deciliter og blodplader ≥75 × 10^9/liter.
  • International Normalized Ratio (INR) ≤1,5 ​​og en partiel tromboplastintid (PTT) ≤5 sekunder over ULN.
  • Kirurgisk steril, postmenopausal eller i overensstemmelse med en yderst effektiv præventionsmetode.
  • Hvis en kvinde i den fødedygtige alder, en negativ serumgraviditetstest før randomisering.
  • Villig til at give blod til forskning. Deltageren har givet underskrevet informeret samtykke forud for undersøgelsesspecifikke procedurer og er i stand til at overholde protokolskemaer og testning.

Ekskluderingskriterier:

  • Fibrolamellært karcinom eller blandet hepatocellulært kolangiokarcinom.
  • Samtidig malignitet. Deltagere med carcinom in situ af enhver oprindelse og deltagere med tidligere maligniteter i remission kan være berettigede med sponsorgodkendelse.
  • Tidligere hjernemetastaser, leptomeningeal sygdom eller ukontrolleret rygmarvskompression.
  • Anamnese med eller nuværende hepatisk encefalopati eller klinisk betydningsfuld ascites.
  • Igangværende eller nyligt hepatorenalt syndrom.
  • Levertransplantation (kun de vigtigste globale og MEE-kohorter; Deltagere med tidligere levertransplantation kan være berettiget til OLE-kohorte).
  • Hepatisk lokoregional terapi efter forudgående systemisk terapi eller inden for 28 dage før randomisering.
  • Større kirurgisk indgreb, traumatisk skade, ikke-helende sår eller mavesår ≤28 dage før randomisering.
  • Modtog stråling til ethvert ikke-hepatisk (for eksempel knogle) sted inden for 14 dage før randomisering.
  • Anbringelse af en subkutan veneadgangsanordning inden for 7 dage før den første dosis af undersøgelsesbehandlingen, medmindre proceduren vurderes at have lav risiko for blødning.
  • Tilmeldt et klinisk forsøg, der involverer et forsøgsprodukt eller ikke-godkendt brug af et lægemiddel eller i medicinsk forskning, der vurderes ikke at være videnskabeligt eller medicinsk forenelig med denne undersøgelse.
  • Afbrudt fra undersøgelsesbehandling fra et andet klinisk forsøg inden for 28 dage før randomisering.
  • Kendt allergi over for nogen af ​​behandlingskomponenterne.
  • Ukontrolleret hypertension.
  • Enhver arteriel trombotisk hændelse, inklusive myokardieinfarkt, ustabil angina, cerebrovaskulær ulykke eller forbigående iskæmisk anfald, <6 måneder før randomisering.
  • Enhver blødningsepisode, der anses for at være livstruende, eller enhver grad 3 eller 4 gastrointestinal blødningsepisode i de 3 måneder forud for randomisering, der kræver intervention.
  • Spiserørs- eller gastriske varicer, der kræver indgreb eller repræsenterer høj blødningsrisiko. Deltagere med tegn på portal hypertension eller tidligere blødning skal have haft en endoskopisk evaluering inden for 3 måneder før randomisering.
  • Gastrointestinal perforation eller fistler inden for 6 måneder før randomisering.
  • Symptomatisk kongestiv hjerteinsufficiens (New York Heart Association II-IV), ustabil angina pectoris eller symptomatisk eller dårligt kontrolleret hjertearytmi.
  • Gravid eller ammende.

  • Enhver medicinsk eller psykiatrisk tilstand, der kan øge risikoen forbundet med undersøgelsesdeltagelse eller kan forstyrre fortolkningen af ​​undersøgelsesresultater. Betingelser omfatter, men er ikke begrænset til:

    • Human immundefektvirusinfektion eller erhvervet immundefektsyndrom-relateret sygdom.
    • Aktiv eller ukontrolleret klinisk alvorlig infektion. (Deltagere med kronisk viral hepatitis er kvalificerede.)
    • Igangværende eller nyere historie med stofmisbrug.
    • Ukontrolleret arvelig eller erhvervet trombotisk eller blødende lidelse.
  • Tarmobstruktion, historie eller tilstedeværelse af inflammatorisk enteropati eller omfattende tarmresektion.
  • Terapeutisk dosis antikoagulering med warfarin, lavmolekylært heparin eller lignende midler.
  • Kronisk terapi med ikke-steroide antiinflammatoriske midler eller andre anti-blodplademidler. Aspirin i doser op til 100 milligram/dag er tilladt.

  • Deltageren har modtaget tidligere immunterapi og oplever eller har oplevet noget af følgende (kun OLE-kohorte):

    • Enhver klinisk signifikant grad ≥3 immunrelateret bivirkning (irAE)
    • Enhver grad af neurologisk eller okulær irAE
    • Enhver grad af immunrelateret pneumonitis, kardiomyopati eller hepatitis
  • Deltageren har modtaget forudgående immunterapi og kræver på tidspunktet for studieindskrivningen steroider eller andre immunsuppressive midler (kun OLE-kohorte).

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ramucirumab + Best Supportive Care (BSC)
8 milligram per kilogram (mg/kg) ramucirumab administreret som en intravenøs (IV) injektion på dag 1 i hver 14-dages cyklus. Deltagerne kan fortsætte behandlingen, indtil seponeringskriterierne er opfyldt.
Medicin: Ramucirumab
Administreret IV
Andre navne:
  • LY3009806
  • Cyramza
Placebo komparator: Placebo + BSC
Placebo administreret IV på dag 1 i hver 14-dages cyklus. Deltagerne kan fortsætte behandlingen, indtil seponeringskriterierne er opfyldt.
Medicin: Ramucirumab
Administreret IV
Andre navne:
  • LY3009806
  • Cyramza
Medicin: Placebo
Administreret IV
Eksperimentel: Open Label Ramucirumab + BSC
8 mg/kg ramucirumab administreret IV på dag 1 i hver 14-dages cyklus. Deltagerne kan fortsætte behandlingen, indtil seponeringskriterierne er opfyldt.
Medicin: Ramucirumab
Administreret IV
Andre navne:
  • LY3009806
  • Cyramza
Eksperimentel: Ramucirumab MEE-kohorte + BSC
8 mg/kg ramucirumab administreret IV på dag 1 i hver 14-dages cyklus. Deltagerne kan fortsætte behandlingen, indtil seponeringskriterierne er opfyldt.
Medicin: Ramucirumab
Administreret IV
Andre navne:
  • LY3009806
  • Cyramza
Placebo komparator: Placebo MEE-kohorte + BSC
Placebo administreret IV på dag 1 i hver 14-dages cyklus. Deltagerne kan fortsætte behandlingen, indtil seponeringskriterierne er opfyldt.
Medicin: Ramucirumab
Administreret IV
Andre navne:
  • LY3009806
  • Cyramza
Medicin: Placebo
Administreret IV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse (OS)
Tidsramme: Fra dato for randomisering til død af enhver årsag (op til 28 måneder)
OS-tiden blev målt fra datoen for randomisering til datoen for død af enhver årsag. Deltagere, der ikke var kendt for at være døde på eller før datoen for data cut-off, OS data blev censureret på den sidste dato (på eller før cut-off datoen), hvor deltageren var kendt for at være i live.
Fra dato for randomisering til død af enhver årsag (op til 28 måneder)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progressionsfri overlevelse (PFS)
Tidsramme: Fra randomisering til objektiv progression eller død af enhver årsag (op til 28 måneder)
Progressionsfri overlevelse er defineret som tiden fra randomiseringsdatoen til datoen for første observation af objektiv progression eller død af enhver årsag.
Fra randomisering til objektiv progression eller død af enhver årsag (op til 28 måneder)
Tid til radiografisk progression
Tidsramme: Fra randomisering til objektiv progression (op til 28 måneder)
Tid til radiografisk progression er defineret som tiden fra datoen for randomisering til datoen for første observation af objektiv progression.
Fra randomisering til objektiv progression (op til 28 måneder)
Procentdel af deltagere med den bedste overordnede respons af komplet respons (CR) eller delvis respons (PR): Objektiv responsrate (ORR)
Tidsramme: Fra randomisering til objektiv progression (op til 28 måneder)
Objektiv responsrate er defineret som den procentdel af deltagere, der opnår den bedste overordnede respons af komplet respons (CR) + delvis respons (PR). ORR = CR + PR. CR er forsvinden af ​​alle ikke-mållæsioner og normalisering af tumormarkørniveau. Alle lymfeknuder skal være ikke-patologiske i størrelse (<10 mm kort akse). PR er mindst et fald på 30 % i summen af ​​diametre af mållæsioner, idet der tages udgangspunkt i sumdiametrene ved baseline. CR: Forsvinden af ​​alle mållæsioner. Eventuelle patologiske lymfeknuder (hvad enten de er mål eller ikke-mål) skal have reduktion i kort akse til <10 mm. Tumormarkørresultater skal være normaliseret. Bedste overordnede respons er klassificeret baseret på de overordnede responser vurderet af undersøgelsesforskere i henhold til responsevalueringskriterier i solide tumorer (RECIST) version 1.1.
Fra randomisering til objektiv progression (op til 28 måneder)
Farmakokinetik (PK): Minimum serumkoncentration (Cmin) før 2., 4., 7. og 10. infusion
Tidsramme: Fordosis, uge ​​2, 6, 12 og 18, dag 1; Op til 3 dage før infusion (14-dages cyklusser)
PK Cmin af Ramucirumab Blodprøver blev udtaget på specificerede tidspunkter og i tilfælde af en infusionsrelateret reaktion til vurdering af ramucirumabs serumkoncentrationer.
Fordosis, uge ​​2, 6, 12 og 18, dag 1; Op til 3 dage før infusion (14-dages cyklusser)
PK: Serumkoncentration maksimum (Cmax) efter 1., 2., 4., 7. og 10. ram-infusion
Tidsramme: Uge 0, 2, 6, 12 og 18, dag 1; 1 time til 1,5 time efter afslutning af infusion (14 dages cyklusser)
PK Cmax for Ramucirumab Blodprøver blev udtaget på specificerede tidspunkter og i tilfælde af en infusionsrelateret reaktion til vurdering af ramucirumabs serumkoncentrationer.
Uge 0, 2, 6, 12 og 18, dag 1; 1 time til 1,5 time efter afslutning af infusion (14 dages cyklusser)
Procentdel af deltagere med anti-ramucirumab-antistoffer
Tidsramme: Fordoseringscyklus 1: 7 dage før første infusion, cyklus 4: 3 dage før infusion, cyklus 7 til opfølgning (op til 28 måneder)
Procentdel af deltagere med positive behandlingsfremkomne anti-lægemiddelantistoffer blev opsummeret efter behandlingsgruppe. En behandlings-emergent ADA (TEADA) blev defineret som: at have en negativ ADA ved baseline og en ADA-titer større end eller lig med 1:20 (dvs. (dvs.), større end 2 gange fra den minimalt nødvendige fortynding på 1: 10) ethvert tidspunkt efter baseline (dvs. behandlingsinduceret); eller en 4-fold eller større ændring i ADA-titer fra baseline for deltagere, der havde en påviselig ADA-titer ved baseline (dvs. behandlingsboostet).
Fordoseringscyklus 1: 7 dage før første infusion, cyklus 4: 3 dage før infusion, cyklus 7 til opfølgning (op til 28 måneder)
Tid til forringelse af funktionel vurdering af kræftterapi (FACT) Hepatobiliært Symptom Index-8 (FHSI-8)
Tidsramme: Fra randomisering til den første dato for observation af forværring (≥ 3-point fald) (op til 28 måneder)
FACT Hepatobiliary Symptom Index (FHSI-8) er et instrument med specifikt fokus på de hyppigste og mest bekymrende symptomer oplevet af deltagere med hepatobiliære maligniteter, herunder mangel på energi, kvalme, smerter, vægttab, smerter i ryggen, træthed, gulsot, mavesmerter eller ubehag. Spørgeskemaet (FHSI-8) blev brugt til at vurdere tiden til forringelse af FSHI-8 totalscore udstedt fra datoen for randomisering til den første dato, hvor forringelsen blev observeret, med forringelsestærsklen defineret som et fald ≥ 3 point fra baseline. I tilfælde af ingen forringelse blev deltagerne censureret på tidspunktet for den sidste FSHI-8-elementoptagelse. FHSI-8 totalscore varierer fra 0 til 32, hvor "0" er en svært symptomatisk deltager, og den højeste score indikerer en asymptomatisk deltager. Kaplan-Meier-metoden Hazard ratio blev brugt til at estimere (Ramucirumab versus Placebo), og 95 % konfidensinterval (CI) (Wald) blev estimeret fra ikke-stratificeret/stratificeret Cox-model.
Fra randomisering til den første dato for observation af forværring (≥ 3-point fald) (op til 28 måneder)
Ændring fra baseline i EuroQol 5-Dimension 5-Level (EQ-5D-5L) spørgeskema
Tidsramme: Fra randomisering til slutningen af ​​undersøgelsen (op til 28 måneder)
EQ-5D-5L er et uspecifikt og standardiseret instrument til brug som et mål for selvrapporteret helbredsstatus (EuroQol Group 1990; Herdman et al. 2011). Deltagerne udfyldte spørgeskemaet på 5 niveauer (ingen problemer, lette problemer, moderate problemer, alvorlige problemer og ekstreme problemer), 5-dimensions (mobilitet, egenomsorg, sædvanlige aktiviteter, smerte/ubehag og angst/depression) vedrørende deres nuværende sundhedstilstand. En unik EQ-5D-5L sundhedstilstandsskala går fra 0 til 100 og defineres ved at kombinere 1 niveau fra hver af de 5 dimensioner. Deltagerne angav deres nuværende helbredstilstand ved at markere på et kontinuum fra 100 (bedst tænkelige sundhedstilstand) til 0 (værst tænkelige sundhedstilstand).
Fra randomisering til slutningen af ​​undersøgelsen (op til 28 måneder)
Tid til forringelse af Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Tidsramme: Fra randomisering til første dato for observation af forringelse (ECOG PS≥2) (op til 28 måneder)
Tid til forringelse af ECOG PS er defineret som tiden fra datoen for randomisering til den første dato, hvor ECOG PS 2 observeres (dvs. forringelse fra baseline status på 0 [fuldt aktiv] eller 1 [begrænset i fysisk anstrengende aktivitet, men ambulerende og i stand til at udføre lettere arbejde]). Deltagere uden PS-forringelse blev censureret ved deres seneste dokumenterede vurderinger på 0 eller 1. Vurderinger inkluderede ECOG Performance Status (PS): 2- Ambulant og i stand til al egenomsorg, men ude af stand til at udføre nogen arbejdsaktiviteter. Op og omkring mere end 50 % af de vågne timer, 3 - Kun i stand til begrænset egenomsorg, bundet til seng eller stol mere end 50 % af de vågne timer, 4 - Fuldstændig invalideret, kan ikke udøve egenomsorg. Fuldstændig begrænset til seng eller stol, 5- Døde.
Fra randomisering til første dato for observation af forringelse (ECOG PS≥2) (op til 28 måneder)

Samarbejdspartnere og efterforskere

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

Sponsor

Eli Lilly and Company

Efterforskere

  • Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST), Eli Lilly and Company

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

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

Studer store datoer

Studiestart (Faktiske)

20. juli 2015

Primær færdiggørelse (Faktiske)

15. marts 2018

Studieafslutning (Faktiske)

19. november 2021

Datoer for studieregistrering

Først indsendt

1. maj 2015

Først indsendt, der opfyldte QC-kriterier

1. maj 2015

Først opslået (Skøn)

6. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. januar 2023

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. december 2022

Sidst verificeret

1. december 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15755
  • I4T-MC-JVDE (Anden identifikator: Eli Lilly and Company)
  • 2014-005068-13 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

Anonymiserede individuelle data på patientniveau vil blive leveret i et sikkert adgangsmiljø efter godkendelse af et forskningsforslag og en underskrevet datadelingsaftale.

IPD-delingstidsramme

Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og EU, alt efter hvad der er senere. Data vil være tilgængelige på ubestemt tid for anmodning.

IPD-delingsadgangskriterier

Et forskningsforslag skal godkendes af et uafhængigt bedømmelsespanel, og forskere skal underskrive en datadelingsaftale.

IPD-deling Understøttende informationstype

  • Studieprotokol
  • Statistisk analyseplan (SAP)
  • Klinisk undersøgelsesrapport (CSR)

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

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