Efficacy and Safety Study of cediranib in combination with olaparib in Patients with Recurrent Platinum-Resistant Ovarian Cancer - CONCERTO

Exclusion Criteria

• 1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• 2.Previous enrollment in the present study.
• 3.Exposure to any IP during the last 4 weeks prior to enrollment.
• 4.Previous treatment with PARP inhibitor. For this study, BSI-201 (iniparib) is not considered as PARPi
• 5.Recent cancer-directed therapies: Radiotherapy (RT) within 4 weeks, chemotherapy or other systemic anti-cancer therapy within 4 weeks, or prior anti-angiogenic treatment (e.g., bevacizumab) within 6 weeks prior to starting treatment
• 6.Cancer antigen-125 (CA-125) only disease without RECIST 1.1 measurable disease
• 7.Major surgical procedure within 2 weeks prior to starting treatment; patients must have recovered from any effects of any major surgery and surgical wound should have healed prior to starting treatment
• 8.Clinically significant signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment
• 9.History of intra-abdominal abscess within 3 months prior to starting treatment
• 10.History of GI perforation. Patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired, there has been no evidence of fistula for at least 6 months prior to starting treatment, and patient is deemed to be at low risk of recurrent fistula
• 11.Other malignancy within the last 5 years
• 12.Persisting ≥Grade 2 CTCAE toxicity (except alopecia and Grade 2 peripheral neuropathy) from previous anti-cancer treatment(s)
• 13.Central nervous system metastases
• 14.Patients with any of the following: History of myocardial infarction within 6 months prior to starting treatment; Unstable angina; Resting electrocardiogram (ECG) with clinically significant abnormal findings; New York Heart Association functional classification of III or IV
• 15.Left ventricular ejection fraction (LVEF) < lower limit of normal (LLN) per institutional guidelines, or <55%, if threshold for normal not otherwise specified by institutional guidelines, for patients with the following risk factors: Prior treatment with anthracyclines; Prior treatment with trastuzumab; Prior central thoracic RT, including exposure of heart to therapeutic doses of ionizing RT; History of myocardial infarction within 6-12 months prior to start of IPs; Prior history of other significant impaired cardiac function
• 16.History of stroke or transient ischemic attack within 6 months
• 17.Uncontrolled intercurrent illness
• 18.Patients with myelodysplastic syndrome (MDS)/ treatment-related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML
• 19.No prior allogenic bone marrow transplant or double umbilical cord blood transplantation
• 20.Known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection on antiviral treatment
• 21.Concomitant use of known strong or moderate CYP3A inhibitors
• 22.Concomitant use of known strong or moderate CYP3A inducers