Key information

Recruitment dates:

20 September, 2016 to 20 June, 2022
(Trial recruitment open)

Trial phase:

phase III

Treatment stage:

recurrence

Trial investigator:

Dr Rebecca Kristeleit, UCLH, London

Tags:

BRCA
relapsed
high grade ovarian cancer
PARP inhibitor
Rucaparib

Acronym:

ARIEL4

Clinical trial locations

Location list

Contact: Royal Marsden Hospital
Address:
SW3 6JJ
Contact: UCLH
Address:
London
NW1 2BU
Contact: East and North Hertfordshire NHS trust
Address:
HA6 2RN
Contact: East and North Hertfordshire NHS trust
Address:
HA6 2RN
Contact: Cambridge University Hospitals NHS Foundation Trust
Address:
CB2 0QQ
Contact: University Hospital of Coventry and Warwickshire NHS trust
Address:
CV2 2DX
Contact: Derby Teaching Hospital NHS foundation trust
Address:
DE22 3NE
Contact: The Christie NHS foundation trust
Address:
M20 4BX
Contact: The Christie NHS foundation trust
Address:
M20 4BX
Contact: Newcastle Hospitals NHS foundation trust
Address:
NE7 7DN
Contact: NHS Greater Glasgow and Clyde
Address:
G12 0XH
Contact: Ninewells Hospital, Dundee
Address:
DD2 1UB
Contact: Velindre Cancer Centre, CARDIFF
Address:
CF14 2TL

Introduction

This is an international phase III trial of the PARP inhibitor rucaparib vs chemotherapy in BRCA1 or BRCA2 positive, relapsed, high grade ovarian cancer.

About the trial

The aim of the trial is to fully understand the benefits of a PARP inhibitor versus standard chemotherapy for BRCA positive women who have had two previous treatments. It is a three arm trial, where women will be randomised to receive:

  • Rucaparib – oral tablets to be taken twice a day in a 28 day cycle
  • Single agent paclitaxel – intravenously for women who are platinum resistant or partially sensitive
  • Single agent platinum or two chemotherapy drugs – to be given at the doctors discretion

NB. There is the option for women on the trial on one of the chemotherapy arms, whose disease progresses, to cross over to the Rucaparib arm.

Who can take part?

Women will have: 

  • relapsed, high grade ovarian, fallopian tube or primary peritoneal cancer
  • had two previous chemotherapy regimens
  • a BRCA  or BRCA2 mutation
  • no prior treatment with PARP inhibitors or single agent paclitaxel

Women will have had a treatment free interval of more than six months following first chemotherapy

 

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.