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)
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)
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression-Free Survival (PFS)
Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).
Measured at baseline until the date of first documented objective disease progression, assessed up to 16 months.
No
Ian Smith, MD
Study Chair
AstraZeneca UK, MSD
United States: Food and Drug Administration
D1532C00064
NCT01750281
December 2012
July 2014
Name | Location |
---|---|
Research Site | Anaheim, California |
Research Site | Boca Raton, Florida |
Research Site | Albany, Georgia |
Research Site | Baton Rouge, Louisiana |
Research Site | Beverly, Massachusetts |
Research Site | Albany, New York |
Research Site | Allentown, Pennsylvania |