Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function

Sponsor
AstraZeneca
Study ID
NCT01894256
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib tablet dosing — DRUG
    Part A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd

Study Details

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.

Key Dates

Start date
Nov 30, 2013
Status verified
Aug 2016
Primary completion
Mar 31, 2015
Completion
Feb 29, 2016

Study Design

Enrollment
56 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL

Arms

  • Other: Normal renal function
    Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation).
  • Other: Mild renal impairment
    Patients with calculated serum creatinine clearance 51-80 mL/min (using Cockcroft-Gault equation).
  • Other: Moderate renal impairment
    Patients with calculated serum creatinine clearance 31-50 mL/min (using Cockcroft-Gault equation).

Primary Outcome Measure

Cmax of Olaparib [ Time Frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose ]

Related Studies