Enzastaurin Versus Lomustine i Glioblastom
10. september 2019 opdateret af: Eli Lilly and Company
Randomiseret fase 3 åbent studie - Enzastaurin vs. Lomustine i glioblastom
Denne protokol vil teste aktiviteten af Enzastaurin vs. Lomustine i behandlingen af tilbagevendende hjernekræft (specifikt intrakranielt glioblastoma multiforme).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
397
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Liverpool, New South Wales, Australien, 2170
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St Leonards, New South Wales, Australien, 2065
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Queensland
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Auchenflower, Queensland, Australien, 4066
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Victoria
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Heidelberg, Victoria, Australien, 3084
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Western Australia
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Nedlands, Western Australia, Australien, 6009
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Brussels, Belgien, 1200
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Leuven, Belgien, B-3000
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Liège, Belgien, 4000
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Ontario
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London, Ontario, Canada, N6A 4L6
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Ottawa, Ontario, Canada, K1H 1C4
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Toronto, Ontario, Canada, M5G 2M9
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Avon
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Bristol, Avon, Det Forenede Kongerige, BS2 8ED
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Cambridgeshire
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Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 2QQ
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Scotland
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Edinburgh, Scotland, Det Forenede Kongerige, EH4 2XU
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Glasgow, Scotland, Det Forenede Kongerige, G11 6NT
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Arizona
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Phoenix, Arizona, Forenede Stater, 85013
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Tucson, Arizona, Forenede Stater, 85724
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California
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Berkeley, California, Forenede Stater, 94704
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Los Angeles, California, Forenede Stater, 90048
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San Francisco, California, Forenede Stater, 94143
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Colorado
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Aurora, Colorado, Forenede Stater, 80010
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Delaware
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Newark, Delaware, Forenede Stater, 19718
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Florida
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Tampa, Florida, Forenede Stater, 33612
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
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Peoria, Illinois, Forenede Stater, 61615
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
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Maryland
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Baltimore, Maryland, Forenede Stater, 21231
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Bethesda, Maryland, Forenede Stater, 20892
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
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Rochester, Minnesota, Forenede Stater, 55905
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
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Saint Louis, Missouri, Forenede Stater, 63110
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89135
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87106
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Santa Fe, New Mexico, Forenede Stater, 87505
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New York
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Buffalo, New York, Forenede Stater, 14226
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New York, New York, Forenede Stater, 10021
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27157
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38138
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Nashville, Tennessee, Forenede Stater, 37203
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Texas
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Dallas, Texas, Forenede Stater, 75246
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Houston, Texas, Forenede Stater, 77030
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Lubbock, Texas, Forenede Stater, 79410
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San Antonio, Texas, Forenede Stater, 78258
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Utah
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Salt Lake City, Utah, Forenede Stater, 84132
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
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Washington
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Seattle, Washington, Forenede Stater, 98195
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
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Lyon, Frankrig, 69395
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Marseille, Frankrig, 13385
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Nancy, Frankrig, 54035
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Paris, Frankrig, 75013
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Poitiers, Frankrig, 86000
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Amsterdam, Holland, 1105 AZ
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Den Haag, Holland, 2512 VA
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Maastricht, Holland, 6229 HX
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Rotterdam, Holland, 3075 EA
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Mumbai, Indien, 400 012
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New Delhi, Indien, 110 029
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Vellore, Indien, 632 004
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Bologna, Italien, 40139
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Milano, Italien, 20133
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Napoli, Italien, 80131
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Roma, Italien, 00128
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Torino, Italien, 10126
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Ciudad Obregon, Mexico, 85100
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Guadalajara, Mexico, 44280
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Mexico City, Mexico, 11640
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Monterrey, Mexico, 64060
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Tijuana, Mexico, 22329
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Tlalpan, Mexico, 14269
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Toluca, Mexico, 52140
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Lublin, Polen, 20-950
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Warsaw, Polen, 02-781
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Badalona, Spanien, 08915
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Hospitalet Llobregat, Spanien, 08907
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Madrid, Spanien, 28040
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Oviedo, Spanien, 33006
- 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.
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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.
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Bonn, Tyskland, D-53105
- 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.
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Dresden, Tyskland, 01307
- 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.
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Freiburg, Tyskland, 79106
- 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.
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Heidelberg, Tyskland, 69120
- 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.
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München, 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.
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Tübingen, 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.
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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.
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Innsbruck, Østrig, 5020
- 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.
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Linz, Østrig, A-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.
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Wien, Østrig, A-1100
- 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.
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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:
- Patient præsenterer med histologisk bekræftet diagnose af hjernekræft (specifikt glioblastoma multiforme).
- Din kræftsygdom er vendt tilbage efter behandling.
- Patienten kan have gennemgået en tidligere operation for at fjerne kræft.
- Patienten skal kunne tage vare på sig selv.
Ekskluderingskriterier:
- Har en anden type kræft (undtagen tilstrækkeligt behandlet basalcellekarcinom i huden). Patient, der tidligere har haft en anden kræftsygdom, skal være fri for kræft i mere end 2 år.
- Har modtaget behandling inden for de sidste 30 dage med et lægemiddel, der ikke har modtaget myndighedsgodkendelse for nogen indikation på tidspunktet for indrejsen.
- Patienter, der får medicin mod anfald, skal afbryde behandlingen 14 dage før tilmelding.
- Kan ikke være på blodfortyndende medicin ved studieindskrivning.
- Kan ikke være på anden medicin for at forebygge kræft ved studieindskrivning.
- Patienter må ikke deltage i undersøgelsen, hvis de tidligere har taget Enzastaurin, Lomustine og/eller Bevacizumab.
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 |
|---|---|
|
Aktiv komparator: B
|
100-130 mg/m2, oral én gang, hver 6. uge indtil PD
|
|
Eksperimentel: EN
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1125 mg startdosis derefter 500 mg, oral, daglig, 6 ugers cyklusser indtil PD
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Det primære formål er at sammenligne Enzastaurin versus Lomustine hos patienter, der for anden gang har hjernekræft (specifikt intrakranielt glioblastom) for at se, hvilken effekt stofferne har på at forhindre sygdommen i at udvikle sig (forværres).
Tidsramme: baseline til målt progressiv sygdom (PD)
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baseline til målt progressiv sygdom (PD)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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At måle overlevelse for at se, hvordan tumoren reagerede på behandlingen, og hvor længe responsen varede ved hjælp af MR (en scanningsteknik).
Tidsramme: tidspunkt for respons på fremadskridende sygdom
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tidspunkt for respons på fremadskridende sygdom
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At måle ændringer i patientens evne til at tage vare på sig selv (dette vil blive bestemt gennem en standardundersøgelse).
Tidsramme: over hele studiet
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over hele studiet
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At måle ændringer fra baseline og en neurologisk undersøgelse.
Tidsramme: baseline, hver cyklus
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baseline, hver cyklus
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At gennemgå alle dårlige reaktioner rapporteret af patienten og opdaget i blodprøver.
Tidsramme: hver cyklus
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hver cyklus
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At gennemgå kræftens effekt på patientens evne til at passe sig selv og på deres generelle helbredstilstand.
Tidsramme: over hele studiet
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over hele studiet
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At bestemme gennem blodprøver, hvor længe medicinen er i patientens krop.
Tidsramme: cyklus 1, cyklus 4
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cyklus 1, cyklus 4
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At gennemgå gennem test af tumor- og blodprøver for at se, om der er grunde til, at nogle patienter reagerede bedre på stofferne end andre patienter.
Tidsramme: baseline, cyklus 2, afslutning på studiet
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baseline, cyklus 2, afslutning på studiet
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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. januar 2006
Primær færdiggørelse (Faktiske)
1. august 2007
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
22. februar 2006
Først indsendt, der opfyldte QC-kriterier
22. februar 2006
Først opslået (Skøn)
24. februar 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Astrocytom
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Glioblastom
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Lomustine
Andre undersøgelses-id-numre
- 9817
- H6Q-MC-JCBF (Anden identifikator: Eli Lilly and Company)
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 .