Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

Exclusion Criteria

• •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca Representative staff and/or staff at the study site);
• •Previous enrollment in the present study;
• •Exposure to any investigational product (IP) within 30 days or 5 half-lives (whichever is longer) prior to start of study treatment;
• •Any previous treatment with a PARP inhibitor, including olaparib;
• •Subjects who have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;
• •Other malignancy within the last 5 years (few exceptions apply);
• •Resting ECG with clinically significant abnormal findings;
• •Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
• •Concomitant use of known strong 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) caused by previous cancer therapy, excluding alopecia;
• •Subjects with MDS/AML or with features suggestive of MDS/AML;
• •Subjects with pneumonitis or at risk of pneumonitis;
• •Subjects with symptomatic uncontrolled brain metastases;
• •Major surgery within 2 weeks of starting study treatment, and subjects must have recovered from any effects of any major surgery;
• •Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection;
• •Breast feeding women;
• •Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus;
• •Subjects with known active hepatitis (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids