SHS_492359 PARM CASZ 16169

A Single Arm, Open-label, Phase IIb Study to Assess the Efficacy and Safety of the Combination of Cediranib and Olaparib Tablets in Women With Recurrent Platinum Resistant Epithelial Ovarian Cancer, Including Fallopian Tube and/or Primary Peritoneal Cancer Who do Not Carry a Deleterious or Suspected Deleterious Germline BRCA Mutation

Select Inclusion Criteria:

Females aged ≥18 years with previous histologically proven diagnosis of high grade serous, high grade endometroid or clear cell ovarian cancer, fallopian tube or primary peritoneal carcinoma
No evidence of deleterious or suspected deleterious germline mutation in BRCA1 or BRCA2 genes
Recurrent platinum-resistant disease; patients with platinum refractory disease are not eligible
CT/MRI evidence of measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy ≥12 weeks
Prior receipt of antiangiogenic treatment
At least three prior lines of chemotherapy for advanced ovarian cancer
Patients must have adequate organ and marrow function
Adequately controlled blood pressure and thyroid function

Select Exclusion Criteria:

Previous treatment with PARP inhibitor. For this study, BSI-201 (iniparib) is not considered as PARPi
Recent cancer-directed therapies
Cancer antigen-125 (CA-125) only disease without RECIST 1.1 measurable disease
Major surgical procedure within 2 weeks prior to starting treatmen
Clinically significant signs of bowel obstruction within 3 months prior to starting treatment
History of intra-abdominal abscess within 3 months prior to starting treatment
History of GI perforation
Other malignancy within the last 5 years
Central nervous system metastases
History of various heart problems (see protocol)
History of stroke or transient ischemic attack within 6 months
Patients with myelodysplastic syndrome (MDS)/ treatment-related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML
Concomitant use of known strong and moderated CYP3A4 inhibitors and inducers
Phase IIb
Min Sung Park, M.D.
Erik Bailey
  • Swedish Medical Center