NCT02161770

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	AZD9291 tablet dosing	Part A - single 80mg oral dose AZD9291 (administered as 1 80mg tablet). Part B - 80mg oral dose AZD9291 od.
PROCEDURE	Pharmacokinetic sampling - AZD9291	Blood sampling to measure AZD9291 pharmacokinetic parameters.
PROCEDURE	Pharmacokinetic sampling - AZ5140 and AZ7550	Blood samples to measure the pharmacokinetic parameters of AZ5104 and AZ7550.

Timeline

• Start date: 2014-12-22
• Primary completion: 2017-05-16
• Completion: 2017-08-22
• First posted: 2014-06-12
• Last updated: 2019-03-08

Locations

19 sites across 6 countries: United States, Belgium, France, South Korea, Spain, United Kingdom