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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
Sponsor: AstraZeneca
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
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
510
Start Date
2013-09-25
Completion Date
2025-12-31
Last Updated
2025-11-19
Healthy Volunteers
No
Interventions
Selumetinib
Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.
Docetaxel
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 in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Pegylated G-CSF
All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
Locations (197)
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Aurora, Colorado, United States
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Pembroke Pines, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Metairie, Louisiana, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Danvers, Massachusetts, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Rosario, Argentina
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Camperdown, Australia
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Chermside, Australia
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Darlinghurst, Australia
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Fitzroy, Australia
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Kogarah, Australia
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Kurralta Park, Australia
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Malvern, Australia
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Wendouree, Australia
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Woodville South, Australia
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Innsbruck, Austria
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Vienna, Austria
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Roeselare, Belgium
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Barretos, Brazil
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Ijuí, Brazil
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Pelotas, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Vratsa, Bulgaria
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Oshawa, Ontario, Canada
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Regina, Saskatchewan, Canada
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Zaragoza, Spain
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Linköping, Sweden
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