Zanzalintinib在复发或进展性脑膜瘤患者中的研究 (STELLAR-201)
一项关于Zanzalintinib治疗复发或进展性脑膜瘤受试者的2期、单臂、多中心、开放标签研究
The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Exelixis Clinical Trials
- 电话号码：1-888-EXELIXIS (888-393-5494)
- 邮箱：druginfo@exelixis.com
研究联系人备份
- 姓名：Backup or International
- 电话号码：650-837-7400
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- 招聘中
- University of Alabama
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Arizona
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Phoenix、Arizona、美国、85054
- 招聘中
- Mayo Clinic_Arizona
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California
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San Francisco、California、美国、94143
- 招聘中
- University of California, San Francisco
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Santa Monica、California、美国、90404
- 招聘中
- Providence - Saint John's Health Center
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Florida
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Jacksonville、Florida、美国、32224
- 招聘中
- Mayo Clinic_Jacksonville
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Miami、Florida、美国、33176
- 招聘中
- Baptist Health Miami Cancer Institute
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Tampa、Florida、美国、33619
- 招聘中
- Tampa General Hospital
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Illinois
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Chicago、Illinois、美国、60611
- 招聘中
- Northwestern University
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Louisiana
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New Orleans、Louisiana、美国、70112
- 招聘中
- LSU Health Science Center
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Massachusetts
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Boston、Massachusetts、美国、02114
- 招聘中
- Massachusetts General Hospital
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Minnesota
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Rochester、Minnesota、美国、55905
- 招聘中
- Mayo Clinic_Rochester
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Missouri
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St Louis、Missouri、美国、63110
- 招聘中
- Washington University School of Medicine
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New York
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New York、New York、美国、10065
- 招聘中
- Memorial Sloan-Kettering Cancer Center
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North Carolina
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Durham、North Carolina、美国、27710
- 招聘中
- Duke University
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Ohio
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Columbus、Ohio、美国、43210
- 招聘中
- The Ohio State University College of Medicine (OSUCOM)
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Rhode Island
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Providence、Rhode Island、美国、02903
- 招聘中
- Brown University Health Cancer Institute
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Texas
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Houston、Texas、美国、77030
- 招聘中
- UT MD Anderson Cancer Center
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San Antonio、Texas、美国、78229
- 招聘中
- UT Health San Antonio Mays Cancer Center
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Virginia
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Fairfax、Virginia、美国、22031
- 招聘中
- Inova Center for Personalized Health
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Wisconsin
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Madison、Wisconsin、美国、53792
- 招聘中
- UW Carbone Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- Histologically confirmed World Health Organization (WHO) grade 1, 2, or 3 meningioma.
- Developed recurrent disease or progressive disease (PD) after receiving standard therapy (for example, surgery and/or radiation) or have been deemed ineligible to receive these therapies. At least 1 prior course of meningioma-directed radiotherapy is required, if not contraindicated.
- Radiologically documented progression of any existing tumor (growth > 15% of the bidimensional enhancing tumor within the prior 6 months or appearance of new lesions (including intra and extracranial manifestations).
- For participants treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval ≥ 24 weeks must have elapsed from completion of therapy to initiation of treatment.
- Measurable disease by RANO meningioma criteria as determined by the investigator, obtained ≤ 14 days prior to initiation of treatment.
- Karnofsky performance status (KPS) ≥ 60%.
- Demonstrate adequate organ and marrow function within 14 days of treatment initiation
Key Exclusion Criteria:
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Prior history of hypertensive encephalopathy at any time.
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Extracranial lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta.
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Contraindication to magnetic resonance imaging (MRI).
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Local therapy (surgery and/or radiation therapy) is indicated per investigator
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Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks or 5 half-lives, whichever is shorter, before initiation of treatment. There is no limit on prior systemic therapies
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Prior Surgery - completed wound healing must occur prior to initiation of treatment; ≥ 8 weeks for major surgery, ≥ 7 days for minor surgery, including stereotactic biopsies.
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The participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- Cardiovascular disorders, including uncontrolled hypertension,
- Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation,
- Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 milliliters [mL]) of red blood within 12 weeks before initiation of treatment or other history of significant bleeding (eg, intracranial hemorrhage/bleeding), or
- Other clinically significant disorders.
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Requirement for hemodialysis or peritoneal dialysis.
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History of solid organ or allogeneic stem cell transplant.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
学习计划
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 |
|---|---|
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实验性的：Zanzalintinib
Participants will receive zanzalintinib once daily (QD). |
Administered as specified in the treatment arm.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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基于盲态独立中心审查（BICR）评估的神经肿瘤学疗效评价标准（RANO）客观缓解率（ORR）
大体时间：最长约12个月
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最长约12个月
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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根据RANO标准由BICR和研究者评估的6个月无进展生存期（PFS-6）
大体时间：最长6个月
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最长6个月
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由BICR和研究者评估的RANO标准下的缓解持续时间（DOR）
大体时间：最长约48个月
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最长约48个月
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经BICR和研究者评估的RANO无进展生存期(PFS)
大体时间：最长约48个月
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最长约48个月
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总生存期（OS）
大体时间：最多约48个月
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最多约48个月
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发生治疗期间出现的不良事件（TEAEs）的参与者人数
大体时间：最长约48个月
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最长约48个月
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通过神经肿瘤学神经功能评估（NANO）量表评分测量的神经功能相对于基线的变化
大体时间：基线至约13个月
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基线至约13个月
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通过欧洲五维健康量表5级版本（EQ-5D-5L）评分测量的健康相关生命质量（HRQoL）相对于基线的变化
大体时间：基线至约13个月
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基线至约13个月
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合作者和调查者
赞助
调查人员
- 研究主任：Study Director、Exelixis
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- XL092-201
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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