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在复发性卵巢颗粒细胞瘤患者中测试药物 Darolutamide 以及药物 Leuprolide Acetate 和 Exemestane 的研究

2026年10月15日 更新者：National Cancer Institute (NCI)

达洛鲁胺联合醋酸亮丙瑞林和依西美坦抑制复发性成人型卵巢颗粒细胞瘤雄激素受体 (AR) 的 II 期研究

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

17

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Exemestane

Given PO

其他名称：
  • 芳香素
  • FCE-24304
程序：Magnetic Resonance Imaging

Undergo MRI

其他名称：
  • 核磁共振
  • 磁共振
  • 磁共振成像扫描
  • 医学影像、磁共振/核磁共振
  • 先生
  • 磁共振成像
  • 核磁共振成像扫描
  • 核磁共振成像
  • 磁共振成像 (MRI)
  • 磁共振成像（程序）
  • 结构核磁共振
程序：Positron Emission Tomography

Undergo PET/CT

其他名称：
  • 医学成像、正电子发射断层扫描
  • 宠物
  • 宠物扫描
  • 正电子发射断层扫描
  • PT
  • 正电子发射断层扫描（程序）
程序：Chest Radiography

Undergo chest x-ray

其他名称：
  • 胸部 X 光
程序：Computed Tomography

Undergo CT and/or PET/CT

其他名称：
  • CT
  • 猫
  • 电脑扫描
  • 计算机轴向断层扫描
  • 计算机断层扫描
  • CT扫描
  • 断层扫描
  • 计算机轴向断层扫描（程序）
  • 计算机断层扫描 (CT) 扫描
  • 诊断猫扫描
  • 诊断猫扫描服务类型
药品：Darolutamide

Given PO

其他名称：
  • ODM-201
  • 努贝卡
  • 抗雄激素ODM-201
  • 湾 1841788
  • BAY-1841788
  • BAY1841788
  • 设计制造商201
  • ODM201
程序：Biospecimen Collection

Undergo archived tissue and blood sample collection

其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
药品：Leuprolide Acetate

Given IM

其他名称：
  • 对映酮
  • LEUP
  • 亮丙瑞林
  • 亮丙瑞林得宝
  • 醋酸亮丙瑞林
  • A-43818
  • 雅培 43818
  • 雅培-43818
  • 肉桂酸
  • 德宝-Eligard
  • 埃利加尔
  • 埃南顿
  • Enantone-Gyn
  • Ginecrin
  • 亮氨酸
  • 卢克林
  • Lucrin 仓库
  • Lupron Depot-3 个月
  • Lupron Depot-4 个月
  • Lupron Depot-Ped
  • 路特酸盐
  • 普罗克伦
  • 普克林
  • 前列腺
  • TAP-144
  • 特宁通
  • 单庚酮
  • 维亚杜尔
  • Luprodex 仓库
  • 43818
  • A43818
  • 芬索尔维
  • 水龙头144
  • 塔普144

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Objective Response Rate (ORR)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Duration of Response
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Cancer Institute (NCI)

合作者

NRG Oncology

调查人员

  • 首席研究员：Elizabeth Hopp、NRG Oncology

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年2月8日

初级完成 (实际的)

2026年2月10日

研究完成 (实际的)

2026年9月28日

研究注册日期

首次提交

2023年12月7日

首先提交符合 QC 标准的

2023年12月7日

首次发布 (实际的)

2023年12月13日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月15日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NCI-2023-06524
  • U10CA180868 (美国 NIH 拨款/合同)
  • NCI-2023-06524 (注册表标识符：CTRP (Clinical Trial Reporting Program))
  • NRG-GY033 (其他标识符：CTEP)
  • NRG-GY033 (其他标识符：NRG Oncology)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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