이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

재발성 난소 과립막 세포 종양 환자를 대상으로 약물 류프롤리드 아세테이트 및 엑세메스탄과 함께 약물 다로루타마이드를 테스트하기 위한 연구

2026년 10월 15일 업데이트: National Cancer Institute (NCI)

재발성 성인형 난소 과립막 세포종양에서 류프롤리드 아세테이트 및 엑세메스탄과 결합한 다롤루타마이드의 안드로겐 수용체(AR) 억제에 대한 제2상 연구

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

17

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Exemestane

Given PO

다른 이름들:
  • 아로마신
  • FCE-24304
절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:
  • MRI
  • 자기 공명
  • 자기공명영상 스캔
  • 의료영상, 자기공명 / 핵자기공명
  • 씨
  • MR 이미징
  • MRI 검사
  • NMR 이미징
  • NMRI
  • 핵자기공명영상
  • 자기공명영상(MRI)
  • SMRI
  • 자기공명영상(시술)
  • 구조적 MRI
절차: Positron Emission Tomography

Undergo PET/CT

다른 이름들:
  • 의료 영상, 양전자 방출 단층 촬영
  • 애완 동물
  • PET 스캔
  • 양전자 방출 단층 촬영 스캔
  • 양전자 방출 단층 촬영
  • PT
  • 양전자방출단층촬영(시술)
절차: Chest Radiography

Undergo chest x-ray

다른 이름들:
  • 흉부 엑스레이
절차: Computed Tomography

Undergo CT and/or PET/CT

다른 이름들:
  • CT
  • 고양이
  • 고양이 스캔
  • 컴퓨터 축 단층 촬영
  • 전산화 단층 촬영
  • CT 스캔
  • 단층 촬영
  • 컴퓨터 축 단층 촬영(시술)
  • 컴퓨터 단층촬영(CT) 스캔
  • 진단 CAT 스캔
  • 진단 CAT 스캔 서비스 유형
의약품: Darolutamide

Given PO

다른 이름들:
  • ODM-201
  • 누베카
  • 항안드로겐 ODM-201
  • 베이 1841788
  • BAY-1841788
  • 베이1841788
  • ODM 201
  • ODM201
절차: Biospecimen Collection

Undergo archived tissue and blood sample collection

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
의약품: Leuprolide Acetate

Given IM

다른 이름들:
  • 에난톤
  • LEUP
  • 루프론
  • 루프론 디포
  • 류프로렐린 아세테이트
  • A-43818
  • 애보트 43818
  • 애보트-43818
  • 카르시닐
  • Depo-Eligard
  • 엘리가드
  • 에난톤-진
  • 지네크린
  • 루플린
  • 루크린
  • 루크린 디포
  • Lupron Depot-3개월
  • Lupron Depot-4개월
  • Lupron Depot-Ped
  • 루트레이트
  • 프로크렌
  • 프로크린
  • 전립선
  • TAP-144
  • 트레난톤
  • 우노에난톤
  • 비아뒤르
  • 루프로덱스 창고
  • 43818
  • A43818
  • 펜솔비
  • 탭 144
  • 탭144

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate (ORR)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Duration of Response
기간: 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)
기간: 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)
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

협력자

NRG Oncology

수사관

  • 수석 연구원: Elizabeth Hopp, NRG Oncology

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 2월 8일

기본 완료 (실제)

2026년 2월 10일

연구 완료 (실제)

2026년 9월 28일

연구 등록 날짜

최초 제출

2023년 12월 7일

QC 기준을 충족하는 최초 제출

2023년 12월 7일

처음 게시됨 (실제)

2023년 12월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 15일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCI-2023-06524
  • U10CA180868 (미국 NIH 보조금/계약)
  • NCI-2023-06524 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • NRG-GY033 (기타 식별자: CTEP)
  • NRG-GY033 (기타 식별자: NRG Oncology)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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