To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

September 1, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

April 29, 2019

Conditions
Solid Tumours
Interventions
DRUG

Olaparib

2 x 150mg tablets, twice daily Day 1-5, and Day 27 onwards (Cohort 1), Day 20 onwards (Cohort 2) or Day 39 onwards (Cohort 3)

DRUG

Tamoxifen

60mg Tamoxifen once daily, Day 10 - Day 13; 20mg Tamoxifen once daily, Day 14 - Day 31

DRUG

Anastrozole

1mg Anastrozole once daily Day 10 - Day 24

DRUG

Letrozole

2.5mg Letrozole once daily Day 10 - Day 43

PROCEDURE

Pharmacokinetic sampling

Blood sampling over 12-24 hour period for pharmacokinetic analysis

Trial Locations (14)

1090

Research Site, Brussels

2610

Research Site, Wilrijk

2650

Research Site, Edegem

2730

Research Site, Herlev

3000

Research Site, Leuven

4000

Research Site, Liège

9000

Research Site, Ghent

33076

Research Site, Bordeaux

1081 HV

Research Site, Amsterdam

3584 CX

Research Site, Utrecht

SE1 9RT

Research Site, London

M20 4BX

Research Site, Manchester

NE7 7DN

Research Site, Newcastle upon Tyne

SM2 5PT

Research Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY