Clinical Trials /

A Study of Onapristone ER in Low Grade Serous Ovarian Cancer and Other Progesterone Receptor Positive Gynecologic Cancers

NCT03909152

Description:

The purpose of this study is to test any good and bad effect of the study drug, onapristone extended-release (ER).

Related Conditions:
  • Endometrial Endometrioid Adenocarcinoma
  • Malignant Ovarian Serous Tumor
  • Ovarian Granulosa Cell Tumor
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Onapristone ER in Gynecologic Cancers That Respond to Progesterone
  • Official Title: Basket Study of the Oral Progesterone Antagonist Onapristone ER (Apristor) in Women With Progesterone Receptor Positive (PR+) Recurrent Granulosa Cell Tumor, Low Grade Serous Ovarian Cancer or Endometrioid Endometrial Cancer

Clinical Trial IDs

  • ORG STUDY ID: 19-061
  • NCT ID: NCT03909152

Conditions

  • Granulosa Cell Ovarian Cancer
  • Low Grade Serous Ovarian/ Primary Peritoneal Cancer
  • Endometrioid Endometrial Cancer

Interventions

DrugSynonymsArms
Onapristone ERPR+ Granulosa cell tumor

Purpose

The purpose of this study is to test any good and bad effect of the study drug, onapristone extended-release (ER).

Trial Arms

NameTypeDescriptionInterventions
PR+ Granulosa cell tumorExperimentalEnrolled 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
  • Onapristone ER
PR+ Low grade serous ovarian cancerExperimentalEnrolled 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
  • Onapristone ER
PR+ Endometrioid endometrial cancerExperimentalEnrolled 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
  • Onapristone ER

Eligibility Criteria

        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.

          -  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 cancer within the 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

Primary Outcome Measures

Measure:response rate
Time Frame:within 36 weeks
Safety Issue:
Description:as determined by RECIST 1.1 response

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Onapristone ER (Apristor)
  • Oral Progesterone
  • Progesterone Receptor Positive (PR+)
  • 19-061

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