AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients
NCT ID: NCT00890825
Last Updated: 2018-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2009-04-20
2016-11-02
Brief Summary
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Detailed Description
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The secondary objectives of the study were:
* To further assess the efficacy of AZD6244 in combination with docetaxel, compared with docetaxel alone, in second-line patients with KRAS mutation-positive locally advanced or metastatic NSCLC
* To assess the safety and tolerability profile of AZD6244 in combination with docetaxel
* To investigate the use of plasma and serum as a potential source of circulating free tumour DNA (cfDNA) for the analysis of KRAS mutation status
* To investigate the PK of AZD6244 and N-desmethyl AZD6244 and any other known metabolites when AZD6244 is administered in combination with docetaxel.
The exploratory objectives of the study were:
* To assess the prevalence, severity and change over time of advanced NSCLC cancer specific symptoms in patients receiving AZD6244 in combination with docetaxel and docetaxel alone
* To explore potential biomarkers in residual tumour, plasma and/or serum taken for KRAS mutational analysis which may influence development of NSCLC (and associated clinical characteristics) and/or response (optional)
* To investigate the relationship between AZD6244 and/or N-desmethyl AZD6244 and any other known metabolite plasma concentrations or exposure and clinical outcomes, efficacy, AEs, and/or safety parameters if deemed appropriate
* To collect and store deoxyribonucleic acid (DNA), derived from a blood sample, for future exploratory research into genes that may influence response, eg, distribution, safety, tolerability, and efficacy of AZD6244 and/or agents used in combination and/or as comparators (optional).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AZD6244 + Docetaxel
AZD6244 75 mg bd + Docetaxel 75 mg/m\^2
AZD6244
oral capsules, 75mg twice daily
docetaxel
75mg/m2 iv on day 1 of every 21 day cycle
Placebo + Docetaxel
Placebo + Docetaxel 75 mg/m\^2
docetaxel
75mg/m2 iv on day 1 of every 21 day cycle
Placebo
placebo
Interventions
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AZD6244
oral capsules, 75mg twice daily
docetaxel
75mg/m2 iv on day 1 of every 21 day cycle
Placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
* Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg Genzyme or Lab 21).
Exclusion Criteria
* Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable)
* Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
* Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month
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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Dr. Pasi Janne
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute, Boston, USA
Dr. Gabriella Mariani
Role: STUDY_DIRECTOR
AstraZeneca, Hertfordshire, UK
Locations
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Research Site
Los Angeles, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Boston, Massachusetts, United States
Research Site
Columbus, Ohio, United States
Research Site
Brussels, , Belgium
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Charleroi, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Liège, , Belgium
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Belo Horizonte, , Brazil
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Ijuí, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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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
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Ostrava, , Czechia
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Prague, , Czechia
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Znojmo, , Czechia
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Brest, , France
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Clermont-Ferrand, , France
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Dijon, , France
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Lyon, , France
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Marseille, , France
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Rennes, , France
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Mosdós, , Hungary
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Székesfehérvár, , Hungary
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Törökbálint, , Hungary
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Bologna, , Italy
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Genova, , Italy
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Milan, , Italy
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Orbassano, , Italy
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Perugia, , Italy
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Roma, , Italy
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Rozzano, , Italy
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México, , Mexico
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Morelia, , Mexico
Research Site
Zacatecas City, , Mexico
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Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
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A Coruña, , Spain
Research Site
Badalona(Barcelona), , Spain
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Countries
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References
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Janne PA, Smith I, McWalter G, Mann H, Dougherty B, Walker J, Orr MC, Hodgson DR, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios CH, Franke FA, Crino L, Smith P. Impact of KRAS codon subtypes from a randomised phase II trial of selumetinib plus docetaxel in KRAS mutant advanced non-small-cell lung cancer. Br J Cancer. 2015 Jul 14;113(2):199-203. doi: 10.1038/bjc.2015.215. Epub 2015 Jun 30.
Janne PA, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios C, Franke FA, Grinsted L, Zazulina V, Smith P, Smith I, Crino L. Selumetinib plus docetaxel for KRAS-mutant advanced non-small-cell lung cancer: a randomised, multicentre, placebo-controlled, phase 2 study. Lancet Oncol. 2013 Jan;14(1):38-47. doi: 10.1016/S1470-2045(12)70489-8. Epub 2012 Nov 28.
Related Links
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Cancer Study Locator (For US and Canada sites only)
Other Identifiers
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D1532C00016
Identifier Type: -
Identifier Source: org_study_id
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