Description:
The purpose of this study is to test any good and bad effect of the study drug, onapristone extended-release (ER) alone and in combination with anastrozole.
The purpose of this study is to test any good and bad effect of the study drug, onapristone extended-release (ER) alone and in combination with anastrozole.
Recruiting
Phase 2
Drug | Synonyms | Arms |
---|---|---|
Onapristone ER | PR+ Endometrioid endometrial cancer | |
Onapristone ER + Anastrozole | PR+ Granulosa cell ovarian cancer |
Name | Type | Description | Interventions |
---|---|---|---|
PR+ Granulosa cell tumor (This Arm is closed) | Experimental | Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days. This Arm is closed. |
|
PR+ Low grade serous ovarian cancer | Experimental | Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days |
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PR+ Endometrioid endometrial cancer | Experimental | Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days |
|
PR+ Granulosa cell ovarian cancer | Experimental | Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart and anastrozole 1mg po QD in AM beginning Day 1 of Cycle 1. A Cycle is 28 days. |
|
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Measure: | response rate |
Time Frame: | within 36 weeks |
Safety Issue: | |
Description: | as determined by RECIST 1.1 response |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
July 7, 2021