Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has
already improved by taking platinum based chemotherapy. The patients must also have a fault
in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the
cells of the body; if this protein doesn't work properly it can increase the chance of
getting cancer. The aim of this study is to see whether patients taking olaparib tablets last
longer until their cancer gets worse, compared to those taking the placebo tablet. The study
is also looking to see if there is an overall improvement to how long the patients survive
whilst taking olaparib tablets compared to the placebo tablets; and the quality of their life
whilst living with ovarian cancer.

Inclusion Criteria:

- Patients must be ≥ 18 years of age.

- Female patients with histologically diagnosed relapsed high grade serous ovarian
cancer (including primary peritoneal and / or fallopian tube cancer) or high
grade endometrioid cancer.

- Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
suspected deleterious (known or predicted to be detrimental/lead to loss of
function).

- Patients who have received at least 2 previous lines of platinum containing
therapy prior to randomisation

For the penultimate chemotherapy course prior to enrolment on the study:

• Patient defined as platinum sensitive after this treatment; defined as disease
progression greater than 6 months after completion of their last dose of platinum
chemotherapy

For the last chemotherapy course immediately prior to randomisation on the study:

- Patients must be, in the opinion of the investigator, in response (partial or complete
radiological response), or may have no evidence of disease (if optimal cytoreductive
surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125,
following completion of this chemotherapy course

- Patient must have received a platinum based chemotherapy regimen (e.g. carboplatin or
cisplatin) and have received at least 4 cycles of treatment

- Patients must be randomized within 8 weeks of their last dose of chemotherapy

- Maintenance treatment is allowed at the end of the penultimate platinum regimen,
including bevacizumab

Exclusion Criteria:

- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site).

- BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental (e.g.,
"Variants of uncertain clinical significance" or "Variant of unknown significance" or
"Variant, favor polymorphism" or "benign polymorphism" etc.)

- Patients who have had drainage of their ascites during the final 2 cycles of their
last chemotherapy regimen prior to enrolment on the study.