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Brief Title: A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer
Official Title: A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 Plus Docetaxel and Placebo Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer Patients
Study ID: NCT02087176
Brief Summary: A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell Lung Cancer Patients
Detailed Description: This multicentre trial consists of an open-labelled single cohort lead-in (Part A) followed by a phase II double-blind, randomised, placebo-controlled comparison of AZD1775 (or placebo) and an antimitotic agent. Review by a central laboratory of fresh tumour or archival tumour samples will be required prior to study entry to assess TP53 mutation status. However, subjects will be allowed to enter the single cohort (Part A) regardless of TP53 mutation status (wild-type or mutant). In addition, patients in the single cohort Part A treatment group will be asked to consent to limited sample collections for assessment of pharmacokinetic parameters.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Birmingham, Alabama, United States
Research Site, Scottsdale, Arizona, United States
Research Site, Fayetteville, Arkansas, United States
Research Site, Englewood, Colorado, United States
Research Site, Orlando, Florida, United States
Research Site, Wichita, Kansas, United States
Research Site, Louisville, Kentucky, United States
Research Site, Durham, North Carolina, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Nashville, Tennessee, United States
Research Site, Milwaukee, Wisconsin, United States
Name: David R Spigel, MD
Affiliation: SCRI Development Innovations, LLC
Role: STUDY_CHAIR