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

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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)

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

212

Study ID:

NCT01750281

Recruitment Status:

Completed

Sponsor:

AstraZeneca

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There are 51 Locations for this study

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Research Site
Santa Monica California, 90404, United States
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Aurora Colorado, 80045, United States
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Hollywood Florida, 33028, United States
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Marrero Louisiana, 70072, United States
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Boston Massachusetts, 02215, United States
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Mineola New York, 11501, United States
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New York New York, 10032, United States
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Philadelphia Pennsylvania, 19107, United States
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Barretos , 14784, Brazil
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Ijuí , 98700, Brazil
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Porto Alegre , 90035, Brazil
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Porto Alegre , 90619, Brazil
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Porto Alegre , 91350, Brazil
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Sao Paulo , 01221, Brazil
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Sao Paulo , 01246, Brazil
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São José do Rio Preto , 15090, Brazil
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São Paulo , 04039, Brazil
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Plovdiv , 4000, Bulgaria
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Plovdiv , 4004, Bulgaria
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Sofia , 1233, Bulgaria
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Sofia , 1303, Bulgaria
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Sofia , 1756, Bulgaria
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Varna , 9010, Bulgaria
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Vratza , 3000, Bulgaria
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Brest Cedex , 29609, France
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Caen , F-140, France
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Clermont Ferrand , 63003, France
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Lille , 59000, France
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Pierre Benite Cedex , 69310, France
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Villejuif , 94805, France
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Essen , 45122, Germany
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Esslingen , 73730, Germany
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Großhansdorf , 22927, Germany
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Karlsruhe , 76137, Germany
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Löwenstein , 74245, Germany
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Moers , 47441, Germany
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Wiesbaden , 65199, Germany
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Würzburg , 97080, Germany
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Budapest , 1121, Hungary
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Budapest , 1122, Hungary
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Edelény , 3780, Hungary
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Kaposvár , 7400, Hungary
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Miskolc , 3529, Hungary
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Nyíregyháza , 4400, Hungary
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Székesfehérvár , 8000, Hungary
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Amsterdam , 1066 , Netherlands
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Amsterdam , 1081 , Netherlands
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Den Bosch , 5223 , Netherlands
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Maastricht , 6202 , Netherlands
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Grudziądz , 86-30, Poland
Research Site
Olsztyn , 10-35, Poland

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

212

Study ID:

NCT01750281

Recruitment Status:

Completed

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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