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Studie för att testa läkemedlet Darolutamid tillsammans med läkemedlen leuprolidacetat och exemestan hos patienter med återkommande ovariegranulosacelltumörer

15 oktober 2026 uppdaterad av: National Cancer Institute (NCI)

En fas II-studie av hämning av androgenreceptorer (AR) av darolutamid i kombination med leuprolidacetat och exemestan i återkommande granulosacelltumörer av vuxentyp

This phase II trial tests how well darolutamide in combination with leuprolide acetate and exemestane works in treating patients with ovarian granulosa cell tumors that have come back after a period of improvement (recurrent). Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Leuprolide acetate is in a class of medications called gonadotropin-releasing hormone agonists. It works by decreasing the amount of certain hormones in the body. Exemestane is in a class of medications called aromatase inhibitors which has anti-estrogen and anticancer activities. Exemestane binds to and inhibits the enzyme aromatase, thereby blocking the conversion of androgens to estrogens. This lowers estrogen levels in the blood circulation causing the tumor cells to grow more slowly or stop growing completely. The combination of darolutamide, leuprolide acetate, and exemestane may be an effective approach to shrinking or stabilizing recurrent ovarian granulosa cell tumors or preventing them from coming back.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVE:

I. To determine the objective response rate of darolutamide, leuprolide acetate, and exemestane in recurrent adult-type granulosa cell tumors of the ovary (AGCT).

SECONDARY OBJECTIVES:

I. To determine duration of response of darolutamide, leuprolide acetate, and exemestane in recurrent adult-type granulosa cell tumors of the ovary (AGCT).

II. To determine progression-free survival of darolutamide, leuprolide acetate, and exemestane when used in recurrent adult-type granulosa cell tumors of ovary (AGCT).

III. To determine overall survival of darolutamide, leuprolide acetate, and exemestane when used in recurrent adult-type granulosa cell tumors of ovary (AGCT).

IV. To elucidate the toxicities of darolutamide, leuprolide acetate, and exemestane when used in recurrent adult-type granulosa cell tumors of ovary (AGCT).

EXPLORATORY OBJECTIVE:

I. To determine biomarkers predictive of response to darolutamide, leuprolide acetate, and exemestane.

OUTLINE:

Patients receive exemestane orally (PO) once daily (QD) and darolutamide PO twice daily (BID) starting on days -14 to -7 prior to cycle 1, day 1 (C1D1) and then on days 1-28 of each cycle. Patients receive leuprolide acetate intramuscularly (IM) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo chest computed tomography (CT) or chest x-ray and CT, magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT as well as blood sample collection throughout the study. Patients undergo collection of archived tissue during screening.

Upon completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Studietyp

Interventionell

Inskrivning (Faktisk)

17

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90048
        • Cedars-Sinai Medical Center
    • Delaware
      • Newark, Delaware, Förenta staterna, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Förenta staterna, 19713
        • Medical Oncology Hematology Consultants PA
    • Idaho
      • Boise, Idaho, Förenta staterna, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell, Idaho, Förenta staterna, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, Förenta staterna, 83814
        • Kootenai Health - Coeur d'Alene
      • Nampa, Idaho, Förenta staterna, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls, Idaho, Förenta staterna, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, Förenta staterna, 83864
        • Kootenai Clinic Cancer Services - Sandpoint
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Northwestern University
      • Danville, Illinois, Förenta staterna, 61832
        • Carle at The Riverfront
      • DeKalb, Illinois, Förenta staterna, 60115
        • Northwestern Medicine Cancer Center Kishwaukee
      • Effingham, Illinois, Förenta staterna, 62401
        • Carle Physician Group-Effingham
      • Geneva, Illinois, Förenta staterna, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Grayslake, Illinois, Förenta staterna, 60030
        • Northwestern Medicine Grayslake Outpatient Center
      • Lake Forest, Illinois, Förenta staterna, 60045
        • Northwestern Medicine Lake Forest Hospital
      • Mattoon, Illinois, Förenta staterna, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Orland Park, Illinois, Förenta staterna, 60462
        • Northwestern Medicine Orland Park
      • Urbana, Illinois, Förenta staterna, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, Förenta staterna, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46260
        • Ascension Saint Vincent Indianapolis Hospital
    • Iowa
      • Iowa City, Iowa, Förenta staterna, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Maine
      • Scarborough, Maine, Förenta staterna, 04074
        • MaineHealth Maine Medical Center- Scarborough
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, Förenta staterna, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Battle Creek, Michigan, Förenta staterna, 49017
        • Bronson Battle Creek
      • Brighton, Michigan, Förenta staterna, 48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Canton, Michigan, Förenta staterna, 48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Chelsea, Michigan, Förenta staterna, 48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Flint, Michigan, Förenta staterna, 48503
        • Hurley Medical Center
      • Flint, Michigan, Förenta staterna, 48503
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Förenta staterna, 48503
        • Genesys Hurley Cancer Institute
      • Flint, Michigan, Förenta staterna, 48503
        • Cancer Hematology Centers - Flint
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, Förenta staterna, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Förenta staterna, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Förenta staterna, 49009
        • Beacon Kalamazoo Cancer Center
      • Livonia, Michigan, Förenta staterna, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Muskegon, Michigan, Förenta staterna, 49444
        • Trinity Health Muskegon Hospital
      • Norton Shores, Michigan, Förenta staterna, 49444
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Reed City, Michigan, Förenta staterna, 49677
        • Corewell Health Reed City Hospital
      • Saint Joseph, Michigan, Förenta staterna, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Traverse City, Michigan, Förenta staterna, 49684
        • Munson Medical Center
      • Wyoming, Michigan, Förenta staterna, 49519
        • University of Michigan Health - West
      • Ypsilanti, Michigan, Förenta staterna, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63141
        • Mercy Hospital Saint Louis
    • Montana
      • Anaconda, Montana, Förenta staterna, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, Förenta staterna, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, Förenta staterna, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, Förenta staterna, 59405
        • Benefis Sletten Cancer Institute
      • Missoula, Montana, Förenta staterna, 59804
        • Community Medical Center
    • Nebraska
      • Omaha, Nebraska, Förenta staterna, 68198
        • University of Nebraska Medical Center
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Concord, North Carolina, Förenta staterna, 28025
        • Atrium Health Cabarrus/LCI-Concord
    • Ohio
      • Centerville, Ohio, Förenta staterna, 45459
        • Miami Valley Hospital South
      • Cleveland, Ohio, Förenta staterna, 44195
        • Cleveland Clinic Foundation
      • Sylvania, Ohio, Förenta staterna, 43560
        • ProMedica Flower Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Ontario, Oregon, Förenta staterna, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, Förenta staterna, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Tualatin, Oregon, Förenta staterna, 97062
        • Legacy Meridian Park Hospital
    • Washington
      • Vancouver, Washington, Förenta staterna, 98686
        • Legacy Salmon Creek Hospital
    • West Virginia
      • Charleston, West Virginia, Förenta staterna, 25304
        • West Virginia University Charleston Division
    • Wisconsin
      • Appleton, Wisconsin, Förenta staterna, 54911
        • ThedaCare Regional Cancer Center
      • Milwaukee, Wisconsin, Förenta staterna, 53226
        • Medical College of Wisconsin

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • Physicians should consider the following when evaluating if the patient is appropriate for this protocol:

    • Patients must have adequate health that permits completion of the study requirements and required follow up

    • For patients with known human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) infection:

      • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
      • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
      • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

    • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

In addition:

  • The effects of the combination of darolutamide, leuprolide acetate, and exemestane on the developing human fetus are unknown. For this reason, and because androgen receptor inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 1 month following the completion of study therapy. Should a participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately

    • Submission of tissue is required. Investigators should check with their pathology department regarding release of tissue before approaching patients about participation in the trial
    • Histologically confirmed diagnosis of recurrent adult-type granulosa cell tumor
    • Patient must have measurable disease. Measurable disease is defined in the protocol per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI
    • Patient must have had ≥1 treatment regimen
    • Subject must have progressed on an aromatase inhibitor (letrozole, exemestane, anastrozole) in a prior treatment line
    • Age ≥ 18 years
    • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
    • Not pregnant and not nursing
    • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
    • Platelets ≥ 100,000 cells/mm^3
    • Hemoglobin ≥ 8 g/dl
    • Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN
    • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
    • No active infection requiring parenteral antibiotics
    • Patients with current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Exclusion Criteria:

  • Prior treatment with AR inhibitors
  • Known hypersensitivity to the study drugs or their ingredients

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Treatment (exemestane, darolutamide, leuprolide acetate)

Patients receive exemestane PO QD and darolutamide PO BID starting on days -14 to -7 prior to C1D1 and then on days 1-28 of each cycle. Patients receive leuprolide acetate IM on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo chest CT or chest x-ray and CT, MRI, or PET/CT as well as blood sample collection throughout the study. Patients undergo collection of archived tissue during screening.
Läkemedel: Exemestane

Given PO

Andra namn:
  • Aromasin
  • FCE-24304
Procedur: Magnetic Resonance Imaging

Undergo MRI

Andra namn:
  • MRI
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
  • HERR
  • MR-avbildning
  • MRI-skanning
  • NMR-avbildning
  • NMRI
  • Kärnmagnetisk resonanstomografi
  • Magnetisk resonanstomografi (MRT)
  • sMRI
  • Magnetisk resonanstomografi (förfarande)
  • Strukturell MRI
Procedur: Positron Emission Tomography

Undergo PET/CT

Andra namn:
  • Medicinsk avbildning, Positron Emission Tomografi
  • SÄLLSKAPSDJUR
  • Djur Scan
  • Positron Emission Tomography Scan
  • Positronemissionstomografi
  • PT
  • Positronemissionstomografi (förfarande)
Procedur: Chest Radiography

Undergo chest x-ray

Andra namn:
  • Bröstkorgsröntgen
Procedur: Computed Tomography

Undergo CT and/or PET/CT

Andra namn:
  • CT
  • KATT
  • Datortomografi
  • Beräknad axiell tomografi
  • Datoriserad axialtomografi
  • tomografi
  • Datoriserad axiell tomografi (förfarande)
  • Datortomografi (CT) skanning
  • Diagnostisk kattskanning
  • Diagnostisk kattskanningstjänsttyp
Läkemedel: Darolutamide

Given PO

Andra namn:
  • ODM-201
  • Nubeqa
  • Antiandrogen ODM-201
  • BAY 1841788
  • BAY-1841788
  • BAY1841788
  • ODM 201
  • ODM201
Procedur: Biospecimen Collection

Undergo archived tissue and blood sample collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Läkemedel: Leuprolide Acetate

Given IM

Andra namn:
  • Enantone
  • LEUP
  • Lupron
  • Lupron Depå
  • Leuprorelinacetat
  • A-43818
  • Abbott 43818
  • Abbott-43818
  • Carcinil
  • Depo-Eligard
  • Eligard
  • Enanton
  • Enantone-Gyn
  • Ginecrin
  • Leuplin
  • Lucrin
  • Lucrin Depå
  • Lupron Depot-3 månader
  • Lupron Depot-4 månader
  • Lupron Depot-Ped
  • Lutrate
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur
  • Luprodex Depå
  • A 43818
  • A43818
  • Fensolvi
  • TAP 144
  • TAP144

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective Response Rate (ORR)
Tidsram: Within 9 months of initiating study treatment

Defined as a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Exact 95% confidence limits, accounting for interim analysis, will be provided in the final report.
Within 9 months of initiating study treatment

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Duration of Response
Tidsram: Within 9 months of initiating study treatment

The duration of overall response is measured from the time measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that recurrence or progressive disease is objectively documented. Only one patient experienced a partial response (PR) within the 9-month response window. Therefore the 95% confidence interval for the duration of response was not estimated.
Within 9 months of initiating study treatment
Progression-free Survival (PFS)
Tidsram: up to 22 months

Progression-free survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact with known progression-free status if neither progression nor death has occurred. Patients with no follow-up will be censored 1 day after enrollment. Will be graphed using Kaplan-Meier methods. Median PFS will be estimated with corresponding 95% confidence intervals.
up to 22 months
Overall Survival (OS)
Tidsram: up to 22 months

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. Patients with no follow-up will be censored 1 day after enrollment. Will be graphed using Kaplan-Meier methods. Median OS will be estimated with corresponding 95% confidence intervals.

The OS was not reached due to the study early termination for futility. Thus the death rate was reported instead of survival time.
up to 22 months
Incidence of Adverse Events
Tidsram: Adverse Events were assessed up to 9 months, All Cause Mortality was assessed up to 22 months.

Common Terminology Criteria for Adverse Events version 5 will be used to grade and categorize adverse events. Safety will be assessed beginning with the initial dose of any treatment. Descriptive statistics, including frequencies of maximum grade of adverse events by term and category will be reported. Adverse events categorized as grade 5 will be individually reported.
Adverse Events were assessed up to 9 months, All Cause Mortality was assessed up to 22 months.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Samarbetspartners

NRG Oncology

Utredare

  • Huvudutredare: Elizabeth Hopp, NRG Oncology

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 februari 2024

Primärt slutförande (Faktisk)

10 februari 2026

Avslutad studie (Faktisk)

28 september 2026

Studieregistreringsdatum

Först inskickad

7 december 2023

Först inskickad som uppfyllde QC-kriterierna

7 december 2023

Första postat (Faktisk)

13 december 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCI-2023-06524
  • U10CA180868 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2023-06524 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • NRG-GY033 (Annan identifierare: CTEP)
  • NRG-GY033 (Annan identifierare: NRG Oncology)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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