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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03909152
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Context Therapeutics
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE April 8, 2019
First Posted Date  ICMJE April 9, 2019
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE May 2, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
response rate [ Time Frame: within 36 weeks ]
as determined by RECIST 1.1 response
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Onapristone ER in Low Grade Serous Ovarian Cancer and Other Progesterone Receptor Positive Gynecologic Cancers
Official Title  ICMJE 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
Brief Summary The purpose of this study is to test any good and bad effect of the study drug, onapristone extended-release (ER).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Granulosa Cell Ovarian Cancer
  • Low Grade Serous Ovarian/ Primary Peritoneal Cancer
  • Endometrioid Endometrial Cancer
Intervention  ICMJE Drug: Onapristone ER
50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Onapristone ER
  • 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
    Intervention: Drug: Onapristone ER
  • 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
    Intervention: Drug: Onapristone ER
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2019)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: GYN cancer
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachel Grisham, MD 646-888-4653 grishamr@mskcc.org
Contact: Chrisann Kyi, MD 646-888-4221 kyic@mskcc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03909152
Other Study ID Numbers  ICMJE 19-061
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Context Therapeutics
Investigators  ICMJE
Principal Investigator: Rachel Grisham, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP