NCT01900028View on ClinicalTrials.gov

To Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib, and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours

PHASE1CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

September 30, 2016

Conditions
Solid Tumours
Interventions
PROCEDURE

Pharmacokinetic sampling

Blood samples taken pre and post dosing with olaparib+/- itraconazole

DRUG

Olaparib tablet dosing

Olaparib tablets: Part A 100mg od, days 1 and 9 only. Part B 10x300mg doses over 5 days (300mg bd).

DRUG

Itraconazole

Itraconazole 200mg od Part A days 5 to 11 only

Trial Locations (14)

2100

Research Site, Copenhagen

2730

Research site, Herlev

3000

Research Site, Leuven

4000

Research Site, Liège

9000

Research Site, Ghent

Unknown

Research Site, Ghent

Research Site, Leuven

Research Site, Liège

Research Site, London

1081 HV

Research Site, Amsterdam

6229 HX

Research Site, Maastricht

6525 GA

Research Site, Nijmegen

NE7 7DN

Research Site, Newcastle

SM2 5PT

Research Site, Sutton

Sponsors

Lead Sponsor

AstraZeneca
All Listed Sponsors
lead

AstraZeneca

INDUSTRY