*ROSY-O
Research type
Research Study
Full title
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
IRAS ID
283571
Contact name
Rosalind Glasspool
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-003777-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 3 months, 1 days
Research summary
This is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using the AZ study drug, Olaparib. The aim of this study is to provide continuous study treatment for participants who are continuing to derive benefits from treatment with Olaparib in the parent study (ORZORA), as deemed fit by the Investigator. The study drug has received marketing regulatory approval in 2014 and this study will continue to investigate the safety and effectiveness of the drug as a stand-alone treatment as per the EU approved prescribing information. Olaparib was assessed for its safety and effectiveness in ORZORA for participants with BRCA (breast cancer) mutated ovarian cancer.
There is no definite number of participants included in this study. All patients across 8 countries from the parent study, ORZORA, who are receiving olaparib will be included in this sub-study.
Participants will receive 300mg of olaparib tablets twice daily and should be taken at the same time each day with addition of lifestyle restrictions. The study will be initiated with an enrolment visit with the participants who will follow up with the treatment on site every 12 weeks and will continue to do so until a discontinuation criterion is met. A follow-up visit will be conducted 30 days after the participant withdraws. There is no maximum duration for taking olaparib.REC name
London - Hampstead Research Ethics Committee
REC reference
21/FT/0057
Date of REC Opinion
22 Jun 2021
REC opinion
Further Information Favourable Opinion