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

Inclusion criteria

• ✓. Negative result for serum hepatitis B surface antigen and hepatitis C antibody
• ✓. Total bilirubin less than or equal to1.5 x institutional ULN, albumin and prothrombin time within normal limits and must not have ascites (unless related to disease under study) or encephalopathy.
• ✓. AST and ALT less than or equal to2.5 x institutional ULN unless liver metastases are present in which case it must be less than or equal to5 x ULN.
• ✓. Male or female, aged at least 18 years.
• ✓. Histological or, where appropriate, cytological confirmation of any malignant solid tumour refractory or resistant to standard therapy or for which no suitable effective standard therapy exists. Tumours in which inhibition of the EGFR pathway is considered relevant by the Investigator are not mandated but are encouraged.
• ✓. ECOG performance status less than or equal to2.
• ✓. Patients must have a life expectancy of greater than or equal to12 weeks, as estimated at the time of screening.
• ✓. Females should be using adequate contraceptive measures and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments; women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the postmenopausal range for the institution; documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation

Exclusion criteria