Study to Assess the Effect of Rifampicin (CYP Inducer) on Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours

Sponsor
AstraZeneca
Study ID
NCT01929603
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Pharmacokinetic sampling — PROCEDURE
    Blood sampling to measure olaparib, rifampicin and 4β-hydroxycholesterol
  • Rifampicin — DRUG
    Rifampicin (CYP inducer) 600mg taken once daily from Day 5 to Day 14 (Part A)
  • Olaparib tablet dosing — DRUG
    Olaparib 300mg tablet taken on Days 1 and 14 (Part A). Part B dosing is 300mg olaparib bi-daily

Study Details

This is a 2-part study in patients with advanced solid tumours. Part A will investigate the effect of rifampicin on the PK parameters of olaparib in patients; Part B will allow patients continued access to olaparib after the PK phase and will provide additional safety data.

Key Dates

Start date
Dec 31, 2013
Status verified
Jan 2017
Primary completion
May 31, 2014
Completion
Nov 30, 2016

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP

Arms

  • Experimental: Olaparib alone, olaparib+rifampicin
    Sequential treatments of olaparib alone followed by olaparib+rifampicin, with a washout period inbetween.

Primary Outcome Measure

Pharmacokinetics of olaparib by assessment of maximum plasma olaparib concentration (Cmax) [ Time Frame: Blood samples are collected on olaparib dosing days (Day 1 and 14) at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post olaparib dose Part A. ]

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