| Eligibility |
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
Exclusion Criteria:
- History of another invasive malignancy (other than non-melanoma skin cancer or
curatively treated in situ carcinoma) with evidence of disease within the past 3 years
- History of prior hormonal therapy (i.e., megesterol acetate, tamoxifen or aromatase
inhibitors) for treatment of cancer within 28 days before starting study drug
- Any psychological, familial, sociological or geographic condition that would
potentially hamper compliance with the study protocol
- Known brain metastasis which have not been treated or showed stability for = 6 months
- Patient has received an oral or IV corticosteroid within the prior 28 days and
requires chronic corticosteroid therapy (excludes use of steroid premeds for CT
allergy)
- Uncontrolled hypertension (systolic BP = 160 mmHg or diastolic BP = 95mmHg) despite
medical treatment. Patients with a history of hypertension are allowed provided blood
pressure is controlled by anti-hypertensive treatment.
- Clinically significant heart disease as evidenced by myocardial infarction or arterial
thrombotic event within the past 6 months, severe or unstable angina, or New York
Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction
measurement of < 50% at baseline
- Refractory nausea and vomiting, requirement for parenteral hydration and/or nutrition,
drainage gastrostomy tube, malabsorption, external biliary shunt, or significant small
bowel resection that would preclude adequate study drug absorption
- Anticipated or ongoing administration of anti-cancer therapies other than those
administered in this study
- Use of any prescription medication during the prior 28 days of first onapristone
dosing that the investigator judges is likely to interfere with onapristone activity;
specifically strong inhibitors or inducers, or sensitive substrates of cytochrome P450
CYP3A4. Investigators should consult the following table of clinically-relevant
products http://medicine.iupui.edu/CLINPHARM/ddis/clinical-table.
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