Olaparib maintenance monotherapy in ovarian cancer
Research type
Research Study
Full title
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy.
IRAS ID
128402
Contact name
Charlie Gourley
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2013-001551-13
Duration of Study in the UK
6 years, 4 months, 16 days
Research summary
Ovarian cancer is the fifth most common cause of death from cancer in women. Standard therapy for advanced ovarian cancer consists of surgery to remove the cancer and platinum-based chemotherapy. The success of this approach is limited and approximately 70% of patients fail to achieve a complete response, or eventually relapse after a varying disease-free interval.
Breast Cancer Susceptibility gene mutation (BRCA1 or BRCA2) is an important risk factor for ovarian cancer and accounts for the majority of hereditary ovarian cancer. Women with BRCA mutations are approximately 10 times more likely to develop ovarian cancer than those without.
Olaparib is an oral therapy that is being developed for the treatment of ovarian cancer. A previous study has shown that olaparib significantly improves the period of time that patients with ovarian cancer are disease free after chemotherapy.
This study will investigate whether giving olaparib to patients with BRCA mutated ovarian cancer after they have completed first line platinum chemotherapy treatment has an effect on increasing the disease free time interval compared with placebo.
Two thirds of the patients recruited will receive olaparib tablets and the other third placebo. After giving consent to take part, patients will attend frequent hospital visits throughout the study. At each visit, assessments will be made to check the patient’s health and see how the study treatment is working
Disease progress will be assessed by CT scans at regular time intervals throughout the study. If a patient's disease progresses they will be withdrawn from study treatment and will be followed for further progression and survival.
Patients may receive study treatment for up to 2 years if their disease remains stable or they are disease-free. At the end of 2 years the patient may continue to receive treatment if the investigator considers it to be in their best interest.
REC name
North East - York Research Ethics Committee
REC reference
13/NE/0201
Date of REC Opinion
21 Aug 2013
REC opinion
Further Information Favourable Opinion