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Clinical trial

AZD9291 First Time In Patients Ascending Dose Study (AURA)

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Last updated:1st Mar 2013

This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

Study Type: Interventional
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD9291 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent
Enrollment: 974
Study Start Date: March 2013
Estimated Study Completion Date: November 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

- Experimental:
Daily dose of AZD9291

Category Value
Study start date 2013-03-01

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