A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.

Exclusion Criteria

• •Patients must not have received bevacizumab during this course of treatment. Bevacizumab use as part of an earlier line of chemotherapy is permitted Patients must not have received any investigational agent during this course of treatment Patients must be randomised within 8 weeks of their last dose of chemotherapy (last dose is the day of the last infusion)
• •Patients must have normal organ and bone marrow function measured within 28 days of randomization.
• •Eastern Cooperative Oncology Group performance status 0-1
• •Patients must have a life expectancy ≥16 weeks.
• •Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1
• •At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment. or No measurable disease following a complete response to most recent chemotherapy (+/- surgery)
• •A formalin fixed, paraffin embedded (FFPE) tumour sample from the cancer of sufficient quantity and quality (as specified in the Covance Central Laboratory Services Manual) must be available for future central testing of tumour genetic status.
• •For inclusion in the optional biomarker research, patients must sign an informed consent for biomarker research.
• •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• •Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomisation.
• •Resting electrocardiogram (ECG) with corrected QT interval (QTc) \>470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome6. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative radiotherapy) within 3 weeks prior to study treatment.
• •Concomitant use of known strong cytochrome P450 (CYP) subfamily 3A (CYP3A) inhibitors or moderate CYP3A inhibitors.
• •Concomitant use of known strong or moderate CYP3A inducers.
• •Persistent toxicities (Common Terminology Criteria for Adverse Event \[CTCAE\] grade 2 or higher) caused by previous cancer therapy, excluding alopecia and stable Grade 2 peripheral neuropathy .
• •Patients with current or previous myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML.
• •Patients with symptomatic uncontrolled brain metastases.
• •Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• •Patients with a known hypersensitivity to Olaparib or any of the excipients of the product.
• •Patients with a known active hepatitis (i.e..Hepatitis B or C).
• •Patient who have received a whole blood transfusion within 30 days prior to screening tests (packed red blood cells and platelet transfusions are acceptable).