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A Study of Onapristone ER in Gynecologic Cancers That Respond to Progesterone

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ClinicalTrials.gov Identifier: NCT03909152
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Context Therapeutics
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

Condition or disease Intervention/treatment Phase
Granulosa Cell Ovarian Cancer Low Grade Serous Ovarian/ Primary Peritoneal Cancer Endometrioid Endometrial Cancer Drug: Onapristone ER Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A non-randomized, open, multicenter phase 2 study.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Experimental: PR+ Granulosa cell tumor
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
Drug: Onapristone ER
50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.

Experimental: PR+ Low grade serous ovarian cancer
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
Drug: Onapristone ER
50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.

Experimental: PR+ Endometrioid endometrial cancer
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
Drug: Onapristone ER
50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.




Primary Outcome Measures :
  1. response rate [ Time Frame: within 36 weeks ]
    as determined by RECIST 1.1 response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   GYN cancer
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909152


Contacts
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Contact: Rachel Grisham, MD 646-888-4653 grishamr@mskcc.org
Contact: David Hyman, MD 646-888-4544

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge Not yet recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Rachel Grisham, MD    646-888-4653      
Memorial Sloan Kettering Monmouth Not yet recruiting
Middletown, New Jersey, United States, 07748
Contact: Rachel Grisham, MD    646-888-4653      
Memorial Sloan Kettering Bergen Not yet recruiting
Montvale, New Jersey, United States, 07645
Contact: Rachel Grisham, MD    646-888-4653      
United States, New York
Memorial Sloan Kettering Commack Not yet recruiting
Commack, New York, United States, 11725
Contact: Rachel Grisham, MD    646-888-4653      
Memorial Sloan Kettering Westchester Not yet recruiting
Harrison, New York, United States, 10604
Contact: Rachel Grisham, MD    646-888-4653      
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Rachel Grisham, MD    646-888-4653      
Contact: Jason Konner, MD    646-888-4219      
Principal Investigator: Rachel Grisham, MD         
Memorial Sloan Kettering Rockville Centre Not yet recruiting
Rockville Centre, New York, United States, 11570
Contact: Rachel Grisham, MD    646-888-4653      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Context Therapeutics
Investigators
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Principal Investigator: Rachel Grisham, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03909152     History of Changes
Other Study ID Numbers: 19-061
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Onapristone ER (Apristor)
Oral Progesterone
Progesterone Receptor Positive (PR+)
19-061

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endometrial Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Uterine Diseases
Progesterone
Onapristone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Hormone Antagonists