Lung Cancer Clinical Trial
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
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
Full 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 Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 191 Locations for this study
Aurora Colorado, 80045, United States
Pembroke Pines Florida, 33028, United States
Atlanta Georgia, 30318, United States
Chicago Illinois, 60637, United States
Metairie Louisiana, 70006, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Danvers Massachusetts, 01923, United States
New York New York, 10011, United States
New York New York, 10032, United States
Durham North Carolina, 27710, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Seattle Washington, 98104, United States
Morgantown West Virginia, 26506, United States
Buenos Aires , 1426, Argentina
Buenos Aires , C1025, Argentina
Ciudad de Buenos Aires , 1180, Argentina
Cordoba , 5000, Argentina
Rosario , S2000, Argentina
Camperdown , 2050, Australia
Chermside , 4032, Australia
Darlinghurst , 2010, Australia
Fitzroy , 3065, Australia
Kogarah , 2217, Australia
Kurralta Park , 5037, Australia
Malvern , 3144, Australia
Wendouree , 3355, Australia
Woodville South , 5011, Australia
Innsbruck , 6020, Austria
Linz , 4020, Austria
Salzburg , 5020, Austria
Vienna , 1160, Austria
Wien , 1100, Austria
Brussels , 1090, Belgium
Bruxelles , 1000, Belgium
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Roeselare , 8800, Belgium
Barretos , 14784, Brazil
Ijui , 98700, Brazil
Pelotas , 09601, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90610, Brazil
Sao Paulo , 01209, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , , Brazil
São José do Rio Preto , 15090, Brazil
Plovdiv , 4000, Bulgaria
Sofia , 1233, Bulgaria
Sofia , 1303, Bulgaria
Sofia , 1330, Bulgaria
Varna , 9010, Bulgaria
Vratza , 3000, Bulgaria
Edmonton Alberta, T6G 1, Canada
Kelowna British Columbia, V1Y 5, Canada
Surrey British Columbia, V3V 1, Canada
Halifax Nova Scotia, B3H 1, Canada
Oshawa Ontario, L1G 2, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H4A 3, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Quebec , G1V 4, Canada
Santiago , 75009, Chile
Santiago , 75203, Chile
Santiago , 76303, Chile
Santiago , 83601, Chile
Santiago , 83804, Chile
Santiago , 84203, Chile
Brest Cedex , 29609, France
Caen , F-140, France
Clermont Ferrand , 63003, France
Dijon , 21079, France
Lille , 59000, France
Marseille Cedex 20 , 13915, France
Paris , 75020, France
Pierre Benite Cedex , 69310, France
RENNES Cedex 9 , 35033, France
Toulouse Cedex 09 , 31059, France
Augsburg , 86156, Germany
Bad Berka , 99437, Germany
Dortmund , 44309, Germany
Gerlingen , 70839, Germany
Großhansdorf , 22927, Germany
Halle , 06120, Germany
Heidelberg , 69126, Germany
Homburg , 66424, Germany
Köln , 50937, Germany
Löwenstein , 74245, Germany
Moers , 47441, Germany
München , 81925, Germany
Ulm , 89081, Germany
Wiesbaden , 65199, Germany
Würzburg , 97080, Germany
Budapest , 1121, Hungary
Budapest , 1122, Hungary
Edelény , 3780, Hungary
Győr , 9024, Hungary
Kaposvár , 7400, Hungary
Miskolc , 3529, Hungary
NyÃregyháza , 4400, Hungary
Törökbálint , 2045, Hungary
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Kfar Saba , 44281, Israel
Petah Tikva , 49100, Israel
Tel Hashomer , 52621, Israel
Tel-Aviv , 64239, Israel
Bari , 70124, Italy
Genova , 16100, Italy
Livorno , 57100, Italy
Milano , 20132, Italy
Napoli , 80131, Italy
Orbassano , 10043, Italy
Parma , 43126, Italy
Perugia , 06132, Italy
Roma , 00128, Italy
Roma , 00144, Italy
Mexico , 14080, Mexico
Monterrey , 64460, Mexico
Amsterdam , 1066 , Netherlands
Amsterdam , 1081 , Netherlands
Bergen Op Zoom , 4624 , Netherlands
Den Bosch , 5223 , Netherlands
Maastricht , 6202 , Netherlands
Lima , 15033, Peru
Lima , 15073, Peru
Lima , L27, Peru
Lima , LIMA , Peru
Lima , LIMA , Peru
Lima , LIMA , Peru
Lima , LIMA , Peru
Miraflores , 15046, Peru
Brzozow , 36-20, Poland
Bydgoszcz , 85-79, Poland
Gdańsk , 80-21, Poland
Gdańsk , 80-21, Poland
GrudziÄ…dz , 86-30, Poland
Kraków , 31-20, Poland
Lubin , 59-30, Poland
Olsztyn , 10-35, Poland
Opole , 45-06, Poland
Sucha Beskidzka , 34-20, Poland
Szczecin , 70-89, Poland
Warszawa , 02-78, Poland
Amadora , 2720-, Portugal
Coimbra , 3040-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1769-, Portugal
Porto , 4100-, Portugal
Porto , 4200-, Portugal
Vila Nova de Gaia , 4434-, Portugal
Cluj Napoca , 40001, Romania
Cluj Napoca , 40005, Romania
Kazan , 42001, Russian Federation
Moscow , 10522, Russian Federation
Moscow , 11547, Russian Federation
Saint Petersburg , 19734, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saint-Petersburg , 19429, Russian Federation
Volgograd , 40013, Russian Federation
Barcelona , 08003, Spain
Madrid , 08035, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Málaga , 29010, Spain
Sevilla , 41013, Spain
Vigo(Pontevedra) , 36204, Spain
Zaragoza , 50009, Spain
Linköping , 581 8, Sweden
Uppsala , SE-75, Sweden
Örebro , 701 8, Sweden
Ankara , 06230, Turkey
Ankara , 06280, Turkey
Istanbul , 34662, Turkey
İstanbul , 34844, Turkey
Izmir , 35100, Turkey
Izmir , 35110, Turkey
Manisa , 45030, Turkey
ChernivtsÑ– , 58013, Ukraine
Dnipro , 49102, Ukraine
Kharkiv Region , 61070, Ukraine
Kryvyi Rih , 50048, Ukraine
Kyiv , 03115, Ukraine
Sumy , 40022, Ukraine
Uzhhorod , 88000, Ukraine
Zaporizhzhia , 69040, Ukraine
Aberdeen , AB2 2, United Kingdom
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Nottingham , NG5 1, United Kingdom
Sutton , SM2 5, United Kingdom
Wolverhampton , WV10 , United Kingdom
How clear is this clinincal trial information?