Spots Global Cancer Trial Database for Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
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Trial Identification
Brief Title: Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
Official Title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 Following a Single Oral Dose to Patients With Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment
Study ID: NCT02161770
Conditions
Study Description
Brief Summary: This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow any patient with mild or moderate hepatic impairment or normal hepatic function, who completes Part A, continued access to AZD9291 after the PK phase and will provide additional safety data.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, San Diego, California, United States
Research Site, Atlanta, Georgia, United States
Research Site, Detroit, Michigan, United States
Research Site, Cleveland, Ohio, United States
Research Site, San Antonio, Texas, United States
Research Site, Gent, , Belgium
Research Site, Woluwé-St-Lambert, , Belgium
Research Site, Angers Cedex 9, , France
Research Site, Marseille Cedex 20, , France
Research Site, Pierre Benite Cedex, , France
Research Site, Rennes, , France
Research Site, Saint Herblain, , France
Research Site, Toulouse, , France
Research Site, Seoul, , Korea, Republic of
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Newcastle Upon Tyne, , United Kingdom
Contact Details
Name: Yuri Rukazenkov
Affiliation: AstraZeneca
Role: STUDY_CHAIR
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