Valutare l'efficacia e la sicurezza di selumetinib in combinazione con docetaxel in pazienti che ricevono un trattamento di 2a linea per NSCLC positivo per v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) (SELECT-1)
Uno studio di fase III, in doppio cieco, randomizzato, controllato con placebo per valutare l'efficacia e la sicurezza di selumetinib (AZD6244; ARRY-142886) (id-solfato) in combinazione con docetaxel, in pazienti che ricevono un trattamento di seconda linea per mutazione KRAS positiva Carcinoma polmonare non a piccole cellule localmente avanzato o metastatico (stadio IIIB - IV) (SELEZIONA 1)
The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Buenos Aires, Argentina, 1426
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Ciudad de Buenos Aires, Argentina, C1025ABI
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Ciudad de Buenos Aires, Argentina, 1180
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Córdoba, Argentina, 5000
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Rosario, Argentina, S2000KZE
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Camperdown, Australia, 2050
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Chermside, Australia, 4032
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Darlinghurst, Australia, 2010
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Fitzroy, Australia, 3065
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Kogarah, Australia, 2217
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Kurralta Park, Australia, 5037
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Malvern, Australia, 3144
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Wendouree, Australia, 3355
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Woodville South, Australia, 5011
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Innsbruck, Austria, 6020
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Linz, Austria, 4020
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Salzburg, Austria, 5020
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Vienna, Austria, 1160
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Vienna, Austria, 1100
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Brussels, Belgio, 1000
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Brussels, Belgio, 1090
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Brussels, Belgio, 1200
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Ghent, Belgio, 9000
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Leuven, Belgio, 3000
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Roeselare, Belgio, 8800
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Barretos, Brasile, 14784-400
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Ijuí, Brasile, 98700-000
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Pelotas, Brasile, 096015-280
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Porto Alegre, Brasile, 90035-003
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Porto Alegre, Brasile, 90610-000
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São José do Rio Preto, Brasile, 15090-000
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São Paulo, Brasile
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São Paulo, Brasile, 01209-000
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São Paulo, Brasile, 01246-000
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Plovdiv, Bulgaria, 4000
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1330
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Sofia, Bulgaria, 1303
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Varna, Bulgaria, 9010
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Vratsa, Bulgaria, 3000
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
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Surrey, British Columbia, Canada, V3V 1Z2
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
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Ontario
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Oshawa, Ontario, Canada, L1G 2B9
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Toronto, Ontario, Canada, M5G 2M9
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
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Québec, Quebec, Canada, G1V 4G5
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Regina, Saskatchewan, Canada, S4T 7T1
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Saskatoon, Saskatchewan, Canada, S7N 4H4
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Santiago, Chile, 7520349
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Santiago, Chile, 8360160
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Santiago, Chile, 7500921
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Santiago, Chile, 8380456
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Santiago, Chile, 8420383
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Santiago, Chile, 7630370
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Brest, Francia, 29609
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Caen, Francia, F-14033
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Clermont-Ferrand, Francia, 63003
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Dijon, Francia, 21079
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Lille, Francia, 59000
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Marseille, Francia, 13915
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Paris, Francia, 75020
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Pierre-Bénite, Francia, 69310
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Rennes, Francia, 35033
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Toulouse, Francia, 31059
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Augsburg, Germania, 86156
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Bad Berka, Germania, 99437
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Cologne, Germania, 50937
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Dortmund, Germania, 44309
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Gerlingen, Germania, 70839
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Großhansdorf, Germania, 22927
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Halle, Germania, 06120
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Heidelberg, Germania, 69126
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Homburg, Germania, 66424
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Löwenstein, Germania, 74245
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Moers, Germania, 47441
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München, Germania, 81925
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Ulm, Germania, 89081
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Wiesbaden, Germania, 65199
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Würzburg, Germania, 97080
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Beersheba, Israele, 8410101
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Haifa, Israele, 31096
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Kfar Saba, Israele, 4428164
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Petah Tikva, Israele, 49100
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Tel Aviv, Israele, 64239
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Tel HaShomer, Israele, 52621
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Bari, Italia, 70124
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Genova, Italia, 16100
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Livorno, Italia, 57100
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Milan, Italia, 20132
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Naples, Italia, 80131
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Orbassano, Italia, 10043
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Parma, Italia, 43126
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Perugia, Italia, 06132
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Roma, Italia, 00128
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Roma, Italia, 00144
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Monterrey, Messico, 64460
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México, Messico, 14080
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's-Hertogenbosch, Olanda, 5223 GZ
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Amsterdam, Olanda, 1066 CX
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Amsterdam, Olanda, 1081 HV
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Bergen op Zoom, Olanda, 4624 VT
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Maastricht, Olanda, 6202 AZ
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Lima, Perù, 15033
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Lima, Perù, L27
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Lima, Perù, LIMA 34
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Lima, Perù, LIMA 01
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Lima, Perù, LIMA 29
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Lima, Perù, LIMA 11
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Lima, Perù, 15073
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Miraflores, Perù, 15046
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Brzozów, Polonia, 36-200
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Bydgoszcz, Polonia, 85-796
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Gdansk, Polonia, 80-952
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Gdansk, Polonia, 80-219
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Grudziądz, Polonia, 86-300
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Krakow, Polonia, 31-202
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Lubin, Polonia, 59-301
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Olsztyn, Polonia, 10-357
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Opole, Polonia, 45-061
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Sucha Beskidzka, Polonia, 34-200
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Szczecin, Polonia, 70-891
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Warsaw, Polonia, 02-781
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Amadora, Portogallo, 2720-276
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Coimbra, Portogallo, 3040-316
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Lisbon, Portogallo, 1769-001
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Lisbon, Portogallo, 1099-023
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Porto, Portogallo, 4200-319
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Porto, Portogallo, 4100-180
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Vila Nova de Gaia, Portogallo, 4434-502
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Aberdeen, Regno Unito, AB2 2ZB
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London, Regno Unito, SW3 6JJ
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Manchester, Regno Unito, M20 4BX
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Nottingham, Regno Unito, NG5 1PB
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Sutton, Regno Unito, SM2 5PT
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Wolverhampton, Regno Unito, WV10 0QP
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Cluj-Napoca, Romania, 400015
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Cluj-Napoca, Romania, 400058
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Kazan', Russia, 420012
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Moscow, Russia, 115478
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Moscow, Russia, 105229
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Saint Petersburg, Russia, 197758
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Saint Petersburg, Russia, 194291
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Saint Petersburg, Russia, 197342
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Volgograd, Russia, 400138
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Barcelona, Spagna, 08003
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Madrid, Spagna, 28034
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Madrid, Spagna, 28041
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Madrid, Spagna, 08035
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Málaga, Spagna, 29010
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Seville, Spagna, 41013
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Vigo(Pontevedra), Spagna, 36204
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Zaragoza, Spagna, 50009
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
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Florida
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Pembroke Pines, Florida, Stati Uniti, 33028
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Georgia
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Atlanta, Georgia, Stati Uniti, 30318
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Illinois
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Chicago, Illinois, Stati Uniti, 60637
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Louisiana
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Metairie, Louisiana, Stati Uniti, 70006
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
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Boston, Massachusetts, Stati Uniti, 02215
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Danvers, Massachusetts, Stati Uniti, 01923
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New York
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New York, New York, Stati Uniti, 10032
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New York, New York, Stati Uniti, 10011
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
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Pennsylvania
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Hershey, Pennsylvania, Stati Uniti, 17033
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Philadelphia, Pennsylvania, Stati Uniti, 19107
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37203
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Nashville, Tennessee, Stati Uniti, 37232
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Washington
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Seattle, Washington, Stati Uniti, 98104
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West Virginia
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Morgantown, West Virginia, Stati Uniti, 26506
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Linköping, Svezia, 581 85
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Uppsala, Svezia, SE-751 85
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Örebro, Svezia, 701 85
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Ankara, Turchia (Türkiye), 06230
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Ankara, Turchia (Türkiye), 06280
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Istanbul, Turchia (Türkiye), 34662
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Istanbul, Turchia (Türkiye), 34844
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Izmir, Turchia (Türkiye), 35100
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Izmir, Turchia (Türkiye), 35110
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Manisa, Turchia (Türkiye), 45030
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Chernivtsі, Ucraina, 58013
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Dnipro, Ucraina, 49102
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Kharkiv Region, Ucraina, 61070
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Kryvyi Rih, Ucraina, 50048
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Kyiv, Ucraina, 03115
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Sumy, Ucraina, 40022
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Uzhhorod, Ucraina, 88000
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Zaporizhzhya, Ucraina, 69040
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Budapest, Ungheria, 1121
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Budapest, Ungheria, 1122
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Edelény, Ungheria, 3780
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Győr, Ungheria, 9024
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Kaposvár, Ungheria, 7400
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Miskolc, Ungheria, 3529
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Nyíregyháza, Ungheria, 4400
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Törökbálint, Ungheria, 2045
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Male or female, aged 18 years or older
- Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
- KRAS mutation positive tumour sample as determined by the designated testing laboratory
- Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
Exclusion Criteria:
- Mixed small cell and non-small cell lung cancer histology.
- Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
- Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
- Other concomitant anti-cancer therapy agents excepts steroids
- Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
- Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Selumetinib + Docetaxel
Three 25mg Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle |
Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.
Altri nomi:
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
Altri nomi:
|
|
Sperimentale: Placebo + Docetaxel
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle. |
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
Altri nomi:
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-Free Survival (PFS)
Lasso di tempo: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
|
Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression) |
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival (OS)
Lasso di tempo: Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
|
Overall Survival is defined as the time from the date of randomisation until death due to any cause. |
Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
|
|
Objective Response Rate (ORR)
Lasso di tempo: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
|
ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result) |
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
|
|
Duration of Response (DoR)
Lasso di tempo: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
|
Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression) |
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
|
|
Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Lasso di tempo: Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
|
The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index. |
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
|
|
Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Lasso di tempo: Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
|
Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index. |
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Pasi Jänne, MD, Dana-Faber Cancer Institute, USA
- Cattedra di studio: Gabriella Mariani, MD, AstraZeneca UK, MSD
Pubblicazioni e link utili
Pubblicazioni generali
- Janne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crino L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial. JAMA. 2017 May 9;317(18):1844-1853. doi: 10.1001/jama.2017.3438.
- Janne PA, Mann H, Ghiorghiu D. Study Design and Rationale for a Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Selumetinib in Combination With Docetaxel as Second-Line Treatment in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer (SELECT-1). Clin Lung Cancer. 2016 Mar;17(2):e1-4. doi: 10.1016/j.cllc.2015.12.010. Epub 2015 Dec 30.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stimato)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Neoplasie per sede
- Neoplasie
- Malattie delle vie respiratorie
- Malattie polmonari
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Processi neoplastici
- Neoplasie polmonari
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Condizioni patologiche, segni e sintomi
- Metastasi neoplastica
- Carcinoma, polmone non a piccole cellule
- Prodotti chimici organici
- Idrocarburi
- Cicloparaffins
- Idrocarburi, aliciclici
- Idrocarburi, ciclici
- Terpeni
- Taxoidi
- Ciclodecani
- Diterpenes
- Docetaxel
- AZD 6244
- pegfilgrastim
Altri numeri di identificazione dello studio
- D1532C00079
- 2013-001676-38 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Periodo di condivisione IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Criteri di accesso alla condivisione IPD
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .