Lung Cancer Clinical Trial
Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.
Summary
The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients
Full Description
A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)
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)
Prospective confirmation of KRAS mutation negative status as determined via an AZ approved 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.
Other concomitant anti-cancer therapy agents except steroids
Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)
The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment.
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There are 51 Locations for this study
Santa Monica California, 90404, United States
Aurora Colorado, 80045, United States
Hollywood Florida, 33028, United States
Marrero Louisiana, 70072, United States
Boston Massachusetts, 02215, United States
Mineola New York, 11501, United States
New York New York, 10032, United States
Philadelphia Pennsylvania, 19107, United States
Barretos , 14784, Brazil
Ijuà , 98700, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90619, Brazil
Porto Alegre , 91350, Brazil
Sao Paulo , 01221, Brazil
Sao Paulo , 01246, Brazil
São José do Rio Preto , 15090, Brazil
São Paulo , 04039, Brazil
Plovdiv , 4000, Bulgaria
Plovdiv , 4004, Bulgaria
Sofia , 1233, Bulgaria
Sofia , 1303, Bulgaria
Sofia , 1756, Bulgaria
Varna , 9010, Bulgaria
Vratza , 3000, Bulgaria
Brest Cedex , 29609, France
Caen , F-140, France
Clermont Ferrand , 63003, France
Lille , 59000, France
Pierre Benite Cedex , 69310, France
Villejuif , 94805, France
Essen , 45122, Germany
Esslingen , 73730, Germany
Großhansdorf , 22927, Germany
Karlsruhe , 76137, Germany
Löwenstein , 74245, Germany
Moers , 47441, Germany
Wiesbaden , 65199, Germany
Würzburg , 97080, Germany
Budapest , 1121, Hungary
Budapest , 1122, Hungary
Edelény , 3780, Hungary
Kaposvár , 7400, Hungary
Miskolc , 3529, Hungary
NyÃregyháza , 4400, Hungary
Székesfehérvár , 8000, Hungary
Amsterdam , 1066 , Netherlands
Amsterdam , 1081 , Netherlands
Den Bosch , 5223 , Netherlands
Maastricht , 6202 , Netherlands
GrudziÄ…dz , 86-30, Poland
Olsztyn , 10-35, Poland
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