Enzastaurin versus Lomustin u glioblastomu
10. září 2019 aktualizováno: Eli Lilly and Company
Randomizovaná otevřená studie fáze 3 – Enzastaurin vs. Lomustin u glioblastomu
Tento protokol bude testovat aktivitu Enzastaurinu vs. Lomustin v léčbě recidivující rakoviny mozku (konkrétně intrakraniálního multiformního glioblastomu).
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
397
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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New South Wales
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Liverpool, New South Wales, Austrálie, 2170
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St Leonards, New South Wales, Austrálie, 2065
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Queensland
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Auchenflower, Queensland, Austrálie, 4066
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Victoria
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Heidelberg, Victoria, Austrálie, 3084
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Western Australia
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Nedlands, Western Australia, Austrálie, 6009
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Brussels, Belgie, 1200
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Leuven, Belgie, B-3000
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Liège, Belgie, 4000
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Lyon, Francie, 69395
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Marseille, Francie, 13385
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Nancy, Francie, 54035
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Paris, Francie, 75013
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Poitiers, Francie, 86000
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Amsterdam, Holandsko, 1105 AZ
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Den Haag, Holandsko, 2512 VA
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Maastricht, Holandsko, 6229 HX
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Rotterdam, Holandsko, 3075 EA
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Mumbai, Indie, 400 012
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New Delhi, Indie, 110 029
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Vellore, Indie, 632 004
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Bologna, Itálie, 40139
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Milano, Itálie, 20133
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Napoli, Itálie, 80131
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Roma, Itálie, 00128
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Torino, Itálie, 10126
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Ontario
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London, Ontario, Kanada, N6A 4L6
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Ottawa, Ontario, Kanada, K1H 1C4
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Toronto, Ontario, Kanada, M5G 2M9
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Ciudad Obregon, Mexiko, 85100
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Guadalajara, Mexiko, 44280
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Mexico City, Mexiko, 11640
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Monterrey, Mexiko, 64060
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Tijuana, Mexiko, 22329
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Tlalpan, Mexiko, 14269
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Toluca, Mexiko, 52140
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Bonn, Německo, D-53105
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Dresden, Německo, 01307
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Freiburg, Německo, 79106
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Heidelberg, Německo, 69120
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München, Německo, 81377
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Tübingen, Německo, 72076
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Lublin, Polsko, 20-950
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Warsaw, Polsko, 02-781
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Graz, Rakousko, 8036
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Innsbruck, Rakousko, 5020
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Linz, Rakousko, A-4020
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Wien, Rakousko, A-1100
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Avon
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Bristol, Avon, Spojené království, BS2 8ED
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Cambridgeshire
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Cambridge, Cambridgeshire, Spojené království, CB2 2QQ
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Scotland
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Edinburgh, Scotland, Spojené království, EH4 2XU
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Glasgow, Scotland, Spojené království, G11 6NT
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Arizona
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Phoenix, Arizona, Spojené státy, 85013
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Tucson, Arizona, Spojené státy, 85724
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California
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Berkeley, California, Spojené státy, 94704
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Los Angeles, California, Spojené státy, 90048
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San Francisco, California, Spojené státy, 94143
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Colorado
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Aurora, Colorado, Spojené státy, 80010
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Delaware
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Newark, Delaware, Spojené státy, 19718
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Florida
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Tampa, Florida, Spojené státy, 33612
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
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Hawaii
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Honolulu, Hawaii, Spojené státy, 96813
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Illinois
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Chicago, Illinois, Spojené státy, 60611
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Peoria, Illinois, Spojené státy, 61615
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Iowa
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Iowa City, Iowa, Spojené státy, 52242
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Kansas
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Kansas City, Kansas, Spojené státy, 66160
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Maryland
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Baltimore, Maryland, Spojené státy, 21231
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Bethesda, Maryland, Spojené státy, 20892
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02114
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Michigan
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Detroit, Michigan, Spojené státy, 48202
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55455
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Rochester, Minnesota, Spojené státy, 55905
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Missouri
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Columbia, Missouri, Spojené státy, 65203
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Saint Louis, Missouri, Spojené státy, 63110
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Nebraska
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Omaha, Nebraska, Spojené státy, 68114
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Nevada
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Las Vegas, Nevada, Spojené státy, 89135
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New Hampshire
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Lebanon, New Hampshire, Spojené státy, 03756
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87106
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Santa Fe, New Mexico, Spojené státy, 87505
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New York
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Buffalo, New York, Spojené státy, 14226
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New York, New York, Spojené státy, 10021
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North Carolina
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Winston-Salem, North Carolina, Spojené státy, 27157
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Ohio
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Columbus, Ohio, Spojené státy, 43210
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15232
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Tennessee
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Memphis, Tennessee, Spojené státy, 38138
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Nashville, Tennessee, Spojené státy, 37203
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Texas
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Dallas, Texas, Spojené státy, 75246
- 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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Houston, Texas, Spojené státy, 77030
- 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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Lubbock, Texas, Spojené státy, 79410
- 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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San Antonio, Texas, Spojené státy, 78258
- 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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Utah
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Salt Lake City, Utah, Spojené státy, 84132
- 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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Virginia
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Charlottesville, Virginia, Spojené státy, 22908
- 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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Washington
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Seattle, Washington, Spojené státy, 98195
- 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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Wisconsin
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Madison, Wisconsin, Spojené státy, 53792
- 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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Badalona, Španělsko, 08915
- 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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Hospitalet Llobregat, Španělsko, 08907
- 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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Madrid, Španělsko, 28040
- 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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Oviedo, Španělsko, 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, Španělsko, 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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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Kritéria pro zařazení:
- Pacient má histologicky potvrzenou diagnózu rakoviny mozku (konkrétně multiformní glioblastom).
- Vaše rakovina se po terapii vrátila.
- Pacient mohl podstoupit předchozí operaci k odstranění rakoviny.
- Pacient musí být schopen se o sebe postarat.
Kritéria vyloučení:
- Máte druhý typ rakoviny (kromě adekvátně léčeného bazaliomu kůže). Pacient, který měl v minulosti jinou rakovinu, musí být bez rakoviny déle než 2 roky.
- Během posledních 30 dnů jste byli léčeni lékem, který v době vstupu nezískal regulační schválení pro žádnou indikaci.
- Pacienti, kteří dostávají léky na záchvaty, musí léčbu přerušit 14 dní před zařazením.
- Při zápisu do studia nesmí užívat léky na ředění krve.
- Při zápisu do studie nemůže užívat jiné léky k prevenci rakoviny.
- Pacientům není umožněn vstup do studie, pokud dříve užívali Enzastaurin, Lomustin a/nebo Bevacizumab.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: B
|
100-130 mg/m2, perorálně jednou, každých 6 týdnů až do PD
|
|
Experimentální: A
|
1125 mg nasycovací dávka, poté 500 mg, perorálně, denně, 6týdenní cykly do PD
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Primárním cílem je porovnat Enzastaurin versus Lomustin u pacientů, kteří mají podruhé rakovinu mozku (konkrétně intrakraniální glioblastom), aby se zjistilo, jaký vliv mají léky na zabránění progresi (zhoršení) onemocnění.
Časové okno: výchozí hodnota k naměřené progresivní nemoci (PD)
|
výchozí hodnota k naměřené progresivní nemoci (PD)
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Měřit přežití, aby se zjistilo, jak nádor reagoval na terapii a jak dlouho odpověď trvala, pomocí MRI (skenovací technika).
Časové okno: doba reakce na progresivní onemocnění
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doba reakce na progresivní onemocnění
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Měřit změny ve schopnosti pacienta postarat se o sebe (to bude stanoveno standardním průzkumem).
Časové okno: nad celou studií
|
nad celou studií
|
|
Měřit změny oproti výchozímu stavu a neurologické vyšetření.
Časové okno: základní linie, každý cyklus
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základní linie, každý cyklus
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Přezkoumat všechny špatné reakce hlášené pacientem a zjištěné v krevních testech.
Časové okno: každý cyklus
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každý cyklus
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Zhodnotit vliv rakoviny na schopnost pacienta postarat se o sebe a na jeho celkový zdravotní stav.
Časové okno: nad celou studií
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nad celou studií
|
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Pomocí krevních testů určit, jak dlouho je lék v těle pacienta.
Časové okno: cyklus 1, cyklus 4
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cyklus 1, cyklus 4
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Prověřit testováním vzorků nádoru a krve, abychom zjistili, zda existují důvody, proč někteří pacienti reagovali na léky lépe než jiní pacienti.
Časové okno: základní linie, cyklus 2, konec studie
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základní linie, cyklus 2, konec studie
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2006
Primární dokončení (Aktuální)
1. srpna 2007
Dokončení studie (Aktuální)
1. května 2014
Termíny zápisu do studia
První předloženo
22. února 2006
První předloženo, které splnilo kritéria kontroly kvality
22. února 2006
První zveřejněno (Odhad)
24. února 2006
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. září 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. září 2019
Naposledy ověřeno
1. září 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle histologického typu
- Novotvary
- Novotvary, žlázové a epiteliální
- Astrocytom
- Gliom
- Novotvary, neuroepiteliální
- Neuroektodermální nádory
- Novotvary, zárodečné buňky a embryonální
- Novotvary, nervová tkáň
- Glioblastom
- Molekulární mechanismy farmakologického působení
- Antineoplastická činidla
- Antineoplastická činidla, Alkylační
- Alkylační činidla
- Lomustin
Další identifikační čísla studie
- 9817
- H6Q-MC-JCBF (Jiný identifikátor: Eli Lilly and Company)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu IPD
Anonymizovaná data na úrovni jednotlivých pacientů budou poskytnuta v prostředí zabezpečeného přístupu po schválení výzkumného návrhu a podepsané dohody o sdílení dat.
Časový rámec sdílení IPD
Údaje jsou k dispozici 6 měsíců po primární publikaci a schválení indikace studované v USA a EU, podle toho, co nastane později.
Data budou k dispozici po neomezenou dobu.
Kritéria přístupu pro sdílení IPD
Návrh výzkumu musí schválit nezávislý hodnotící panel a výzkumní pracovníci musí podepsat dohodu o sdílení dat.
Typ podpůrných informací pro sdílení IPD
- Protokol studie
- Plán statistické analýzy (SAP)
- Zpráva o klinické studii (CSR)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .