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En undersøgelse af Tasisulam-natrium versus Paclitaxel som behandling for metastatisk melanom (SUMMIT-1)

18. juni 2018 opdateret af: Eli Lilly and Company

Et randomiseret fase 3-studie af Tasisulam-natrium administreret som en intravenøs infusion på dag 1 af en 28-dages cyklus versus paclitaxel som andenlinjebehandling hos patienter med metastatisk melanom

Det primære formål med denne undersøgelse var at se, hvordan tasisulam-natrium påvirkede metastatisk melanom sammenlignet med paclitaxel målt ved samlet overlevelse.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

336

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Coffs Harbour, New South Wales, Australien, 2450
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      • Wollongong, New South Wales, Australien, 2500
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    • Queensland
      • Townsville, Queensland, Australien, 4810
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      • Woolloongabba, Queensland, Australien, 4102
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    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
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  • Belgien
      • Antwerp, Belgien, 2020
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      • Brussels, Belgien, 1200
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      • Leuven, Belgien, 3000
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  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
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    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
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      • Toronto, Ontario, Canada, M5G 2M9
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    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
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  • Det Forenede Kongerige
      • Manchester, Det Forenede Kongerige, M20 4BX
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    • Cambridgeshire
      • Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
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    • Greater London
      • London, Greater London, Det Forenede Kongerige, SW3 6JJ
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    • Hants
      • Southampton, Hants, Det Forenede Kongerige, SO16 6YD
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    • London
      • Hampstead, London, Det Forenede Kongerige, NW3 2QG
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    • Middlesex
      • Northwood, Middlesex, Det Forenede Kongerige, HA6 2RN
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  • Finland
      • Tampere, Finland, 33520
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      • Turku, Finland, 20520
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  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35243
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    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85258
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      • Tucson, Arizona, Forenede Stater, 85724
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    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
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    • California
      • Fresno, California, Forenede Stater, 93720
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      • Los Angeles, California, Forenede Stater, 90025
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      • San Francisco, California, Forenede Stater, 94115
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    • Florida
      • Fort Myers, Florida, Forenede Stater, 33916
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      • Jacksonville, Florida, Forenede Stater, 32207
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      • Lakeland, Florida, Forenede Stater, 33805
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      • Orlando, Florida, Forenede Stater, 32806
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      • West Palm Beach, Florida, Forenede Stater, 33401
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    • Georgia
      • Augusta, Georgia, Forenede Stater, 30901
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    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
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      • Park Ridge, Illinois, Forenede Stater, 60068
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    • Indiana
      • Goshen, Indiana, Forenede Stater, 46526
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      • Indianapolis, Indiana, Forenede Stater, 46260
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    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
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    • Kansas
      • Westwood, Kansas, Forenede Stater, 66205
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      • Wichita, Kansas, Forenede Stater, 67214
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    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40402
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    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
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    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
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      • Rochester, Minnesota, Forenede Stater, 55905
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    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
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      • Saint Louis, Missouri, Forenede Stater, 63110
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    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
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    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89135
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    • New Jersey
      • Morristown, New Jersey, Forenede Stater, 07960
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    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
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      • Winston-Salem, North Carolina, Forenede Stater, 27157
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    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
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    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45236
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      • Cleveland, Ohio, Forenede Stater, 44106
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      • Columbus, Ohio, Forenede Stater, 43219
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      • Toledo, Ohio, Forenede Stater, 43623
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    • Pennsylvania
      • Bethlehem, Pennsylvania, Forenede Stater, 18015
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      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
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    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
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      • Columbia, South Carolina, Forenede Stater, 29210
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    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
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    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38138
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      • Nashville, Tennessee, Forenede Stater, 37203
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    • Texas
      • Dallas, Texas, Forenede Stater, 75390
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      • La Porte, Texas, Forenede Stater, 77571
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      • The Woodlands, Texas, Forenede Stater, 77380
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    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
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    • Virginia
      • Richmond, Virginia, Forenede Stater, 23230
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    • Washington
      • Seattle, Washington, Forenede Stater, 98109
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    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53717
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  • Frankrig
      • Bordeaux, Frankrig, 33075
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      • Dijon, Frankrig, 21034
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      • Grenoble, Frankrig, 38049
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      • Marseille, Frankrig, 13385
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      • Nantes, Frankrig, 44093
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      • Paris, Frankrig, 75475
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      • Toulouse, Frankrig, 31059
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      • Villejuif, Frankrig, 94805
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  • Holland
      • Leiden, Holland, 2300 RC
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      • Maastricht, Holland, 6229 HX
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      • Rotterdam, Holland, 3015 GD
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  • Israel
      • Jerusalem, Israel, 91120
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      • Tel Hashomer, Israel, 52661
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      • Tel-Aviv, Israel, 64239
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  • Italien
      • Genova, Italien, 16132
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      • Milano, Italien, 20141
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      • Napoli, Italien, 80131
        • 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
        • 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.
      • Siena, Italien, 53100
        • 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.
  • Korea, Republikken
      • Goyang-Si, Korea, Republikken, 411-764
        • 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, 110-744
        • 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.
  • Norge
      • Oslo, Norge, 0310
        • 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.
      • Trondheim, Norge, 7006
        • 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
      • Bialystok, Polen, 15-027
        • 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.
      • Gdansk, Polen, 80-952
        • 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.
      • Otwock, Polen, 05-400
        • 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.
  • Spanien
      • Barcelona, Spanien, 08036
        • 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.
      • Madrid, Spanien, 28046
        • 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.
      • Pamplona, Spanien, 31008
        • 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, 46014
        • 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.
  • Sverige
      • Malmo, Sverige, 20502
        • 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.
      • Stockholm, Sverige, 11883
        • 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
      • Changhua, Taiwan, 500
        • 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.
      • Niao Sung Hsiang, 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.
      • Taipei, Taiwan, 100
        • 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.
      • Tao-Yuan, Taiwan, 333
        • 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
      • Berlin, Tyskland, 10117
        • 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.
      • Buxtehude, Tyskland, 21614
        • 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, D-45147
        • 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, 30449
        • 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.
      • Heilbronn, Tyskland, D-74078
        • 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.
      • Kiel, Tyskland, 24105
        • 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.
      • Koeln, Tyskland, 50937
        • 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.
      • Muenchen, Tyskland, 80337
        • 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.
      • Muenster, Tyskland, 48157
        • 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.
      • Quedlinburg, Tyskland, 06484
        • 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.
      • Tuebingen, 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
      • Graz, Østrig, 8036
        • 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.
      • Innsbruck, Østrig, 6020
        • 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.
      • Vienna, Østrig, A1090
        • 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:

  • Har en histologisk og/eller cytologisk diagnose af metastatisk melanom (stadie IV).
  • Har tilstedeværelsen af ​​evaluerbar sygdom som defineret af responsevalueringskriterierne i solide tumorer (RECIST 1.0).
  • Har en præstationsstatus på 0-1 på Eastern Cooperative Oncology Group (ECOG) skalaen.
  • Har udviklet sig efter 1 tidligere systemisk behandling indeholdende dacarbazin eller temozolomid for metastatisk melanom.
  • Har ophørt med alle tidligere behandlinger for cancer, inklusive kemoterapi, strålebehandling, immunterapi eller anden undersøgelsesterapi i mindst 30 dage (6 uger for mitomycin-C eller nitrosoureas) før undersøgelsesindskrivning og er kommet sig over de akutte virkninger af behandlingen (undtagen alopeci).
  • Har et serumalbuminniveau større end eller lig med 3,0 gram pr. deciliter (g/dL) eller større end eller lig med 30 gram pr. liter (g/L).

Ekskluderingskriterier:

  • Har modtaget mere end eller lig med 2 tidligere kemoterapi-holdige systemiske behandlingsregimer for metastatisk melanom. Et immunterapi- eller antistofbaseret regime (herunder biologiske midler og vaccinationsbaserede behandlinger) eller behandling med et målrettet middel (f.eks. BRAF eller c-Kit-hæmmer tælles ikke som et tidligere behandlingsregime til bestemmelse af studiets egnethed, medmindre enten var kombineret med et cellegift).
  • Har aktivt centralnervesystem (CNS) eller leptomeningeal metastase (hjernemetastase) på tidspunktet for studiestart. Deltagere med tegn eller symptomer på neurologisk kompromittering bør have foretaget passende røntgenbilleder før studiestart for at udelukke okkulte hjernemetastaser. Deltagere med en historie med en solitær CNS-metastase, der tidligere er behandlet med helbredende hensigter (f.eks. stereotaktisk stråling eller kirurgi), og som ikke har krævet steroider, er kvalificerede.
  • Får warfarin.
  • Har primært okulært eller slimhindemelanom.
  • Enhver tidligere behandling med paclitaxel eller et paclitaxel-holdigt regime til metastatisk melanom.
  • Har alvorlige samtidige lidelser, herunder aktiv bakteriel, svampe- eller viral infektion, der er uforenelige med undersøgelsen (efter investigatorens skøn).
  • Har tidligere gennemført eller trukket sig fra denne undersøgelse eller enhver anden undersøgelse, der undersøger tasisulam-natrium.
  • Har en kendt overfølsomhed over for paclitaxel eller Cremophor EL (polyoxyethyleret ricinusolie).
  • Er gravid eller ammer.
  • Har modtaget en nylig (inden for 30 dage før tilmelding) eller modtager samtidig gul feber-vaccination.
  • Har kendte positive testresultater for humant immundefektvirus (HIV), hepatitis B overfladeantigen (HBSAg) eller hepatitis C-antistoffer (HCAb).
  • Er ude af stand til at tilbageholde dosering af non-steroide antiinflammatoriske lægemidler (NSAID'er) eller protonpumpehæmmere (PPI'er) i mindst 72 timer før og efter behandling med tasisulam-natrium.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tasisulam-natrium
Individualiseret tasisulam-natriumdosis var afhængig af deltagerens højde, vægt og køn. Dosis blev justeret baseret på laboratorieparametre. Behandlingen blev administreret intravenøst ​​på dag 1 i en 28-dages cyklus indtil sygdomsprogression.
Medicin: Tasisulam-natrium
Indgivet intravenøst ​​på dag 1 i en 28-dages cyklus indtil sygdomsprogression.
Andre navne:
  • LY573636
Aktiv komparator: Paclitaxel
Paclitaxel 80 milligram per kvadratmeter (mg/m^2) administreret intravenøst ​​på dag 1, 8 og 15 i en 28-dages cyklus, indtil sygdomsprogression
Medicin: Paclitaxel
80 mg/m^2 administreret intravenøst ​​på dag 1, 8 og 15 i en 28-dages cyklus indtil sygdomsprogression

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse (OS)
Tidsramme: Randomisering til dødsdato uanset årsag (vurderet ved hver cyklus og hver 60. dag efter behandlingsophør) op til 14,32 måneder
OS er varigheden fra indskrivning til død; OS censureret for deltagere, der var i live ved sidste kontakt.
Randomisering til dødsdato uanset årsag (vurderet ved hver cyklus og hver 60. dag efter behandlingsophør) op til 14,32 måneder

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progressionsfri overlevelse (PFS)
Tidsramme: Randomisering til dato af objektivt bestemt PD eller død af enhver årsag (vurderet ved hver cyklus og hver 60. dag efter behandlingsophør) op til 13,70 måneder
PFS er tiden fra datoen for første dosis til første observation af sygdomsprogression (PD); PD=20 % stigning i summen af ​​den længste diameter af mållæsioner eller død af enhver årsag.
Randomisering til dato af objektivt bestemt PD eller død af enhver årsag (vurderet ved hver cyklus og hver 60. dag efter behandlingsophør) op til 13,70 måneder
Procentdel af randomiserede deltagere, der har en bekræftet bedste respons af delvis respons (PR) eller komplet respons (CR)
Tidsramme: Første dato RECIST kriterier opfyldt for CR eller PR (alt efter hvad der indtrådte først) indtil første dato for dokumenteret PD, eller død af enhver årsag (vurderet hver anden cyklus) op til 13,70 måneder
Kriterier for responsevaluering i faste tumorer (RECIST): CR=forsvinden af ​​alle mållæsioner; PR=30 % fald i summen af ​​mållæsioners længste diameter; Progressiv sygdom (PD)=20 % stigning i summen af ​​den længste diameter af mållæsioner.
Første dato RECIST kriterier opfyldt for CR eller PR (alt efter hvad der indtrådte først) indtil første dato for dokumenteret PD, eller død af enhver årsag (vurderet hver anden cyklus) op til 13,70 måneder
Varighed af respons (DoR) for deltagere, der har en objektiv respons på delvis respons (PR) eller komplet respons (CR)
Tidsramme: Første dato RECIST kriterier opfyldt for CR eller PR (alt efter hvad der indtrådte først) indtil første dato for dokumenteret PD, eller død af enhver årsag (vurderet hver anden cyklus) op til 13,70 måneder
Respons ved brug af responsevalueringskriterier i solide tumorer (RECIST) kriterier: CR=forsvinden af ​​alle mållæsioner; PR=30 % fald i summen af ​​mållæsioners længste diameter; Progressiv sygdom (PD)=20 % stigning i summen af ​​den længste diameter af mållæsioner. Analyse blev justeret for baseline lactatdehydrogenase (LDH); Sygdomsstadium; Køn; Tidligere Single Agent Immunotherapy Treatment; Aldersgruppe. På grund af begrænset antal svar for begge behandlingsarme blev DoR-analyse ikke udført.
Første dato RECIST kriterier opfyldt for CR eller PR (alt efter hvad der indtrådte først) indtil første dato for dokumenteret PD, eller død af enhver årsag (vurderet hver anden cyklus) op til 13,70 måneder
Procentdel af randomiserede deltagere, der har en bekræftet bedste overordnede respons af delvis respons (PR) eller komplet respons (CR) plus deltagere med en samlet respons af stabil sygdom (SD)
Tidsramme: Første dato RECIST kriterier opfyldt for CR, PR eller SD indtil første dato for dokumenteret progressiv sygdom (PD) eller død af enhver årsag (vurderet hver anden cyklus) op til 13,70 måneder
Respons ved brug af responsevalueringskriterier i solide tumorer (RECIST) kriterier: CR=forsvinden af ​​alle mållæsioner; PR=30 % fald i summen af ​​mållæsioners længste diameter; SD=små ændringer, der ikke opfylder ovenstående kriterier; PD=20 % stigning i summen af ​​den længste diameter af mållæsioner.
Første dato RECIST kriterier opfyldt for CR, PR eller SD indtil første dato for dokumenteret progressiv sygdom (PD) eller død af enhver årsag (vurderet hver anden cyklus) op til 13,70 måneder
Tid til forringelse af den funktionelle vurdering af resultatindeks for kræftterapi-melanomforsøg (FACT-M TOI) Score
Tidsramme: Randomisering til første dato for forværring af FACT-M TOI eller død af enhver årsag (vurderet hver cyklus og op til 30 dage efter behandlingsophør) op til 13,21 måneder
FACT-M måler domæner for sundhedsrelateret livskvalitet (HR-QoL): fysisk velvære, socialt/familiens velvære, følelsesmæssigt velvære, funktionelt velvære og yderligere bekymringer ved melanom. FACT-M TOI er summen af ​​FACT-M fysisk velvære, funktionelt velvære og melanom subskalaer. Score varierer fra 0 til 120; Højere score = bedre livskvalitet (QoL). FACT-M TOI-scoreforringelse blev defineret som tid fra randomisering til en minimalt vigtig forskel i TOI-score eller død.
Randomisering til første dato for forværring af FACT-M TOI eller død af enhver årsag (vurderet hver cyklus og op til 30 dage efter behandlingsophør) op til 13,21 måneder
Ændring fra baseline ved cyklus 2 i funktionel vurdering af kræftterapi-melanom (FACT-M) op til 30 dage efter seponering af behandling
Tidsramme: Baseline ved cyklus 2, op til 30 dage efter seponering af behandlingen
FACT-M måler domæner for sundhedsrelateret livskvalitet (HR-QoL): fysisk velvære, socialt/familiens velvære, følelsesmæssigt velvære, funktionelt velvære og yderligere bekymringer ved melanom. Samlet score spænder fra 0 til 172; Højere score = bedre HR-QoL. Mindste kvadraters (LS) Middelværdi blev justeret for behandlingsgruppe, cyklus, behandling-for-cyklus interaktion, alder, Eastern Cooperative Oncology Group (ECOG) præstationsstatus, sygdomsstadie ved studiestart og bedste respons på tidligere kemoterapi.
Baseline ved cyklus 2, op til 30 dage efter seponering af behandlingen
Ændring fra baseline ved cyklus 3 i funktionel vurdering af kræftterapi-melanom (FACT-M) op til 30 dage efter seponering af behandling
Tidsramme: Baseline ved cyklus 3, op til 30 dage efter behandlingsophør
FACT-M måler domæner for sundhedsrelateret livskvalitet (HR-QoL): fysisk velvære, socialt/familiens velvære, følelsesmæssigt velvære, funktionelt velvære og yderligere bekymringer ved melanom. Samlet score spænder fra 0 til 172; Højere score = bedre HR-QoL. Mindste kvadraters (LS) Middelværdi blev justeret for behandlingsgruppe, cyklus, behandling-for-cyklus interaktion, alder, Eastern Cooperative Oncology Group (ECOG) præstationsstatus, sygdomsstadie ved studiestart og bedste respons på tidligere kemoterapi.
Baseline ved cyklus 3, op til 30 dage efter behandlingsophør
Ændring fra baseline ved cyklus 4 i funktionel vurdering af kræftterapi-melanom (FACT-M) op til 30 dage efter seponering af behandling
Tidsramme: Baseline ved cyklus 4, op til 30 dage efter seponering af behandlingen
FACT-M måler domæner for sundhedsrelateret livskvalitet (HR-QoL): fysisk velvære, socialt/familiens velvære, følelsesmæssigt velvære, funktionelt velvære og yderligere bekymringer ved melanom. Samlet score spænder fra 0 til 172; Højere score = bedre HR-QoL. Mindste kvadraters (LS) Middelværdi blev justeret for behandlingsgruppe, cyklus, behandling-for-cyklus interaktion, alder, Eastern Cooperative Oncology Group (ECOG) præstationsstatus, sygdomsstadie ved studiestart og bedste respons på tidligere kemoterapi.
Baseline ved cyklus 4, op til 30 dage efter seponering af behandlingen
Ændring fra baseline ved cyklus 2 i EuroQol-5 Dimensions (EQ-5D) op til 30 dage efter behandlingsophør
Tidsramme: Baseline ved cyklus 2, op til 30 dage efter seponering af behandlingen
EQ-5D består af 5 punkter, der vurderer deltagerens generelle helbred. Deltagerne vælger 1 af 3 muligheder, der bedst beskriver status for hvert element. EQ-5D Storbritannien (UK)-baserede indeksscore varierer fra -0,59 (dårligst helbred) til 1,0 (1,0=perfekt sundhed; positiv ændring fra baseline=sundhedsforbedring). Mindste kvadraters (LS) Middelværdi blev justeret for behandlingsgruppe, cyklus, behandling-for-cyklus interaktion, alder, Eastern Cooperative Oncology Group (ECOG) præstationsstatus, sygdomsstadie ved studiestart og bedste respons på tidligere kemoterapi.
Baseline ved cyklus 2, op til 30 dage efter seponering af behandlingen
Ændring fra baseline ved cyklus 3 i EuroQol-5 Dimensions (EQ-5D) op til 30 dage efter behandlingsophør
Tidsramme: Baseline ved cyklus 3, op til 30 dage efter behandlingsophør
EQ-5D består af 5 punkter, der vurderer deltagerens generelle helbred. Deltagerne vælger 1 af 3 muligheder, der bedst beskriver status for hvert element. EQ-5D Storbritannien (UK)-baserede indeksscore varierer fra -0,59 (dårligst helbred) til 1,0 (1,0=perfekt sundhed; positiv ændring fra baseline=sundhedsforbedring). Mindste kvadraters (LS) Middelværdi blev justeret for behandlingsgruppe, cyklus, behandling-for-cyklus interaktion, alder, Eastern Cooperative Oncology Group (ECOG) præstationsstatus, sygdomsstadie ved studiestart og bedste respons på tidligere kemoterapi.
Baseline ved cyklus 3, op til 30 dage efter behandlingsophør
Ændring fra baseline ved cyklus 4 baseline i EuroQol-5 Dimensions (EQ-5D) op til 30 dage efter behandlingsophør
Tidsramme: Baseline ved cyklus 4, op til 30 dage efter seponering af behandlingen
EQ-5D består af 5 punkter, der vurderer deltagerens generelle helbred. Deltagerne vælger 1 af 3 muligheder, der bedst beskriver status for hvert element. EQ-5D Storbritannien (UK)-baserede indeksscore varierer fra -0,59 (dårligst helbred) til 1,0 (1,0=perfekt sundhed; positiv ændring fra baseline=sundhedsforbedring). Mindste kvadraters (LS) Middelværdi blev justeret for behandlingsgruppe, cyklus, behandling-for-cyklus interaktion, alder, Eastern Cooperative Oncology Group (ECOG) præstationsstatus, sygdomsstadie ved studiestart og bedste respons på tidligere kemoterapi.
Baseline ved cyklus 4, op til 30 dage efter seponering af behandlingen
Farmakokinetik (PK): Maksimal plasmakoncentration (Cmax) under cyklus 1
Tidsramme: Efter lægemiddelinfusion i cyklus 1 (5 prøver udtaget over en 28-dages cyklus)
Efter lægemiddelinfusion i cyklus 1 (5 prøver udtaget over en 28-dages cyklus)
Farmakokinetik: Maksimal plasmakoncentration (Cmax) under cyklus 2
Tidsramme: Efter lægemiddelinfusion i cyklus 2 (2 prøver udtaget over en 28-dages cyklus)
Efter lægemiddelinfusion i cyklus 2 (2 prøver udtaget over en 28-dages cyklus)

Samarbejdspartnere og efterforskere

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

Sponsor

Eli Lilly and Company

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

1. december 2009

Primær færdiggørelse (Faktiske)

1. marts 2011

Studieafslutning (Faktiske)

1. marts 2011

Datoer for studieregistrering

Først indsendt

30. oktober 2009

Først indsendt, der opfyldte QC-kriterier

30. oktober 2009

Først opslået (Skøn)

1. november 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 13101
  • H8K-MC-JZAO (Anden identifikator: Eli Lilly and Company)

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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