Conditions: Solid Tumours
Keywords: oncology, cancer, neoplasm, anticancer drug, pharmacokinetics, area under curve, olaparib, solid tumour, mild renal impairment, moderate renal impairment
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief 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 renal impairment compared to patients with normal renal function; Part B will allow eligible study patients continued access to olaparib after the PK phase and will provide additional safety data.

Detailed description:

Arms:
arm 1: Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). arm 2: Patients with calculated serum creatinine clearance 51-80 mL/min (using Cockcroft-Gault equation). arm 3: Patients with calculated serum creatinine clearance 31-50 mL/min (using Cockcroft-Gault equation).

Interventions: intervention 1: Olaparib tablet dosing
Intervention descriptions: intervention 1: Part A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd

Protocol document: