A Study of Onapristone ER Alone Or In Combination With Anastrozole in Gynecologic Cancers That Respond to Progesterone

Inclusion Criteria

• •Histologically confirmed diagnosis at MSK of either (1) granulosa cell ovarian cancer, (2) low grade serous ovarian/ primary peritoneal cancer, or (3) endometrioid endometrial cancer; with PR expression ≥1% by IHC on archival tissue taken within the prior 3 years or new biopsy if no archival tissue is available. IHC results do not have to be from MSK.
• •Measurable disease as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be ≥10mm when measured by CT or MRI. Lymph nodes must be ≥15mm in short axis when measured by CT or MRI
• •Patients must have had one prior chemotherapy regimen for management of disease. Note: additional lines of chemotherapy, biologic or immunotherapy are allowed.
• •Recovery from effects of recent surgery, radiotherapy, or chemotherapy
• •At least 4 weeks out from their last dose of radiation therapy
• •At least 4 weeks post-op from any major surgical procedure
• •At least 3 weeks out from their last dose of chemotherapy and/or biologic/targeted therapy
• •Must be ≥ 18 years of age
• •Karnofsky Performance Status (KPS) of ≥ 70%
• •Women of child-bearing potential must have a negative pregnancy test within 14 days prior to commencement of study treatment
• •Women of child bearing potential must use an effective form of contraception during study and for at least 6 months after completion of study treatment
• •Laboratory Test Findings performed within 14 days prior to initiation of study drug showing:
• •Bone marrow function:
• •* Absolute neutrophil count (ANC) ≥ 1,000/mcL
• •* Platelets ≥ 75,000/mcL
• •* Hemoglobin ≥ 8 g/dL
• •Renal function:
• •°Creatinine ≤ 1.5 x ULN
• •Hepatic function:
• •* Bilirubin ≤ 1.5 x ULN
• •* AST and ALT ≤ 2.5 x ULN
• •Resolution of all acute toxic effects of prior therapy to NCI CTCAE (Version 5.0) Grade ≤ 1, with the exception of unresolved Grade 2 neuropathy and Grade 2 alopecia, which are allowed
• •Patient has recovered from any prior radiotherapy
• •Patients must be able to swallow tablets whole, without crushing