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Spots Global Cancer Trial Database for A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: David R Spigel, MD

Affiliation: SCRI Development Innovations, LLC

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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