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

Phase 1

Completed

• Conditions: Solid Tumours
• Interventions: Drug: Olaparib tablet dosing

• Registration Number: NCT01894256
• Lead Sponsor: AstraZeneca

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

Not available

Study Timeline

• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2013-07-04
• Study First Posted: 2013-07-10
• Study Start: 2013-11
• Primary Completion: 2015-03
• Study Completion: 2016-02
• Results First Submitted: 2016-03-18
• Results First Submitted QC: 2016-03-18
• Results First Posted: 2016-04-19
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal renal function	Olaparib tablet dosing	Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation).
Moderate renal impairment	Olaparib tablet dosing	Patients with calculated serum creatinine clearance 31-50 mL/min (using Cockcroft-Gault equation).
Mild renal impairment	Olaparib tablet dosing	Patients with calculated serum creatinine clearance 51-80 mL/min (using Cockcroft-Gault equation).

Primary Outcome Measures

Name	Time	Method
CLR of Olaparib	Part A: Day 1, 0-12 hours and 12-24 hours post-dose	Renal clearance of olaparib, calculated as the ratio of amount of drug excreted over 24 hours to AUC0-24
t1/2 of Olaparib	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	Terminal half-life of olaparib
Cmax of Olaparib	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	Maximum plasma drug concentration of olaparib
AUC of Olaparib	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	Area under plasma concentration-time curve from zero to infinity of olaparib
AUC0-t of Olaparib	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	Area under plasma concentration-time curve from zero to the last measurable time point of olaparib
Tmax of Olaparib	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	Time to reach maximum plasma concentration of olaparib
Vz/F of Olaparib	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	Apparent volume of distribution of olaparib
CL/F of Olaparib	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	Apparent plasma clearance of olaparib

Trial Locations

Locations (1)

Research Site; 🇬🇧 Surrey, United Kingdom