Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.
NCT ID: NCT01750281
Last Updated: 2023-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
212 participants
INTERVENTIONAL
2012-12-18
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2
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.
Selumetinib 75 mg
Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.
Docetaxel 75 mg/m2
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2
Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Selumetinib 75 mg
Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.
Docetaxel 60 mg/m2
Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Placebo twice daily + Docetaxel 75 mg/m2
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
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Placebo
Three placebo capsules will be administered orally uninterrupted twice daily.
Interventions
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Selumetinib 75 mg
Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.
Docetaxel 75 mg/m2
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Docetaxel 60 mg/m2
Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Placebo
Three placebo capsules will be administered orally uninterrupted twice daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Gabriella Mariani, MD
Role: STUDY_CHAIR
AstraZeneca UK, MSD
Pasi Janne, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute, USA
Jean-Charles Soria, MD
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancerology Gustave Roussy, France
Locations
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Research Site
Santa Monica, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Hollywood, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Marrero, Louisiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Mineola, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Barretos, , Brazil
Research Site
Brasília, , Brazil
Research Site
Ijuí, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Porto Alegre, , Brazil
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Porto Alegre, , Brazil
Research Site
Santo André, , Brazil
Research Site
São José do Rio Preto, , Brazil
Research Site
São Paulo, , Brazil
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São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Plovdiv, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
Research Site
Vratsa, , Bulgaria
Research Site
Brest, , France
Research Site
Caen, , France
Research Site
Clermont-Ferrand, , France
Research Site
Lille, , France
Research Site
Pierre-Bénite, , France
Research Site
Villejuif, , France
Research Site
Essen, , Germany
Research Site
Esslingen am Neckar, , Germany
Research Site
Großhansdorf, , Germany
Research Site
Karlsruhe, , Germany
Research Site
Löwenstein, , Germany
Research Site
Moers, , Germany
Research Site
Wiesbaden, , Germany
Research Site
Würzburg, , Germany
Research Site
Budapest, , Hungary
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
Székesfehérvár, , Hungary
Research Site
Törökbálint, , Hungary
Research Site
's-Hertogenbosch, , Netherlands
Research Site
Amsterdam, , Netherlands
Research Site
Amsterdam, , Netherlands
Research Site
Bergen op Zoom, , Netherlands
Research Site
Maastricht, , Netherlands
Research Site
Gdansk, , Poland
Research Site
Grudziądz, , Poland
Research Site
Krakow, , Poland
Research Site
Olsztyn, , Poland
Research Site
Poznan, , Poland
Research Site
Sucha Beskidzka, , Poland
Research Site
Szczecin, , Poland
Countries
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References
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Soria JC, Fulop A, Maciel C, Fischer JR, Girotto G, Lago S, Smit E, Ostoros G, Eberhardt WEE, Lishkovska P, Lovick S, Mariani G, McKeown A, Kilgour E, Smith P, Bowen K, Kohlmann A, Carlile DJ, Janne PA. SELECT-2: a phase II, double-blind, randomized, placebo-controlled study to assess the efficacy of selumetinib plus docetaxel as a second-line treatment of patients with advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2017 Dec 1;28(12):3028-3036. doi: 10.1093/annonc/mdx628.
Related Links
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Other Identifiers
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2012-003622-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1532C00064
Identifier Type: -
Identifier Source: org_study_id
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