drugset / Trial / NCT01894243

Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment

NCT01894243

Phase 1 Completed 31 enrolled AstraZeneca
Non-randomizedParallel-groupOpen-labelOther

Summary

This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow patients with mild or moderate hepatic impairment or normal hepatic function continued access to olaparib after the PK phase and will provide additional safety data.

Timeline

Start
2014-03-13
Primary completion
2016-11-29
Completion
2017-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 300 mg Oral

Indications