Spots Global Cancer Trial Database for Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
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Trial Identification
Brief Title: Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
Official Title: 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)
Study ID: NCT01933932
Study Description
Brief Summary: 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
Detailed Description: 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)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Aurora, Colorado, United States
Research Site, Pembroke Pines, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Metairie, Louisiana, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Danvers, Massachusetts, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Durham, North Carolina, United States
Research Site, Hershey, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Nashville, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Seattle, Washington, United States
Research Site, Morgantown, West Virginia, United States
Research Site, Buenos Aires, , Argentina
Research Site, Buenos Aires, , Argentina
Research Site, Ciudad de Buenos Aires, , Argentina
Research Site, Cordoba, , Argentina
Research Site, Rosario, , Argentina
Research Site, Camperdown, , Australia
Research Site, Chermside, , Australia
Research Site, Darlinghurst, , Australia
Research Site, Fitzroy, , Australia
Research Site, Kogarah, , Australia
Research Site, Kurralta Park, , Australia
Research Site, Malvern, , Australia
Research Site, Wendouree, , Australia
Research Site, Woodville South, , Australia
Research Site, Innsbruck, , Austria
Research Site, Linz, , Austria
Research Site, Salzburg, , Austria
Research Site, Vienna, , Austria
Research Site, Wien, , Austria
Research Site, Brussels, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Gent, , Belgium
Research Site, Leuven, , Belgium
Research Site, Roeselare, , Belgium
Research Site, Barretos, , Brazil
Research Site, Ijui, , Brazil
Research Site, Pelotas, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São José do Rio Preto, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Plovdiv, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Varna, , Bulgaria
Research Site, Vratza, , Bulgaria
Research Site, Edmonton, Alberta, Canada
Research Site, Kelowna, British Columbia, Canada
Research Site, Surrey, British Columbia, Canada
Research Site, Halifax, Nova Scotia, Canada
Research Site, Oshawa, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Regina, Saskatchewan, Canada
Research Site, Saskatoon, Saskatchewan, Canada
Research Site, Quebec, , Canada
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Brest Cedex, , France
Research Site, Caen, , France
Research Site, Clermont Ferrand, , France
Research Site, Dijon, , France
Research Site, Lille, , France
Research Site, Marseille Cedex 20, , France
Research Site, Paris, , France
Research Site, Pierre Benite Cedex, , France
Research Site, RENNES Cedex 9, , France
Research Site, Toulouse Cedex 09, , France
Research Site, Augsburg, , Germany
Research Site, Bad Berka, , Germany
Research Site, Dortmund, , Germany
Research Site, Gerlingen, , Germany
Research Site, Grosshansdorf, , Germany
Research Site, Halle, , Germany
Research Site, Heidelberg, , Germany
Research Site, Homburg, , Germany
Research Site, Köln, , Germany
Research Site, Löwenstein, , Germany
Research Site, Moers, , Germany
Research Site, München, , Germany
Research Site, Ulm, , Germany
Research Site, Wiesbaden, , Germany
Research Site, Würzburg, , Germany
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Edelény, , Hungary
Research Site, Győr, , Hungary
Research Site, Kaposvár, , Hungary
Research Site, Miskolc, , Hungary
Research Site, Nyíregyháza, , Hungary
Research Site, Törökbálint, , Hungary
Research Site, Beer Sheva, , Israel
Research Site, Haifa, , Israel
Research Site, Kfar Saba, , Israel
Research Site, Petah Tikva, , Israel
Research Site, Tel Hashomer, , Israel
Research Site, Tel-Aviv, , Israel
Research Site, Bari, , Italy
Research Site, Genova, , Italy
Research Site, Livorno, , Italy
Research Site, Milano, , Italy
Research Site, Napoli, , Italy
Research Site, Orbassano, , Italy
Research Site, Parma, , Italy
Research Site, Perugia, , Italy
Research Site, Roma, , Italy
Research Site, Roma, , Italy
Research Site, Mexico, , Mexico
Research Site, Monterrey, , Mexico
Research Site, Amsterdam, , Netherlands
Research Site, Amsterdam, , Netherlands
Research Site, Bergen Op Zoom, , Netherlands
Research Site, Den Bosch, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Miraflores, , Peru
Research Site, Brzozow, , Poland
Research Site, Bydgoszcz, , Poland
Research Site, Gdańsk, , Poland
Research Site, Gdańsk, , Poland
Research Site, Grudziądz, , Poland
Research Site, Kraków, , Poland
Research Site, Lubin, , Poland
Research Site, Olsztyn, , Poland
Research Site, Opole, , Poland
Research Site, Sucha Beskidzka, , Poland
Research Site, Szczecin, , Poland
Research Site, Warszawa, , Poland
Research Site, Amadora, , Portugal
Research Site, Coimbra, , Portugal
Research Site, Lisboa, , Portugal
Research Site, Lisboa, , Portugal
Research Site, Porto, , Portugal
Research Site, Porto, , Portugal
Research Site, Vila Nova de Gaia, , Portugal
Research Site, Cluj Napoca, , Romania
Research Site, Cluj Napoca, , Romania
Research Site, Kazan, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Volgograd, , Russian Federation
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Málaga, , Spain
Research Site, Sevilla, , Spain
Research Site, Vigo(Pontevedra), , Spain
Research Site, Zaragoza, , Spain
Research Site, Linköping, , Sweden
Research Site, Uppsala, , Sweden
Research Site, Örebro, , Sweden
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Istanbul, , Turkey
Research Site, İstanbul, , Turkey
Research Site, Izmir, , Turkey
Research Site, Izmir, , Turkey
Research Site, Manisa, , Turkey
Research Site, Chernivtsі, , Ukraine
Research Site, Dnipro, , Ukraine
Research Site, Kharkiv Region, , Ukraine
Research Site, Kryvyi Rih, , Ukraine
Research Site, Kyiv, , Ukraine
Research Site, Sumy, , Ukraine
Research Site, Uzhhorod, , Ukraine
Research Site, Zaporizhzhia, , Ukraine
Research Site, Aberdeen, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Nottingham, , United Kingdom
Research Site, Sutton, , United Kingdom
Research Site, Wolverhampton, , United Kingdom
Contact Details
Name: Gabriella Mariani, MD
Affiliation: AstraZeneca UK, MSD
Role: STUDY_CHAIR
Name: Pasi Jänne, MD
Affiliation: Dana-Faber Cancer Institute, USA
Role: PRINCIPAL_INVESTIGATOR
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