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

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.

Timeline

Start

2014-12-22

Primary completion

2017-05-16

Completion

2017-08-22

Publications

• Grande E, Harvey RD, You B, Batlle JF, Galbraith H, Sarantopoulos J, Ramalingam SS, Mann H, So K, Johnson M, Vishwanathan K. Pharmacokinetic Study of Osimertinib in Cancer Patients with Mild or Moderate Hepatic Impairment. J Pharmacol Exp Ther. 2019 May;369(2):291-299. doi: 10.1124/jpet.118.255919. Epub 2019 Mar 14.

Drugs

Indications