NCT07428616
尚未招募
2 期
A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
干预措施Zanzalintinib
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Exelixis
- 入组人数
- 100
- 主要终点
- Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR)
概览
简要总结
The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prior history of hypertensive encephalopathy at any time.
- •Extracranial lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta.
- •Contraindication to magnetic resonance imaging (MRI).
- •Local therapy (surgery and/or radiation therapy) is indicated per investigator
- •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
- •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.
- •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
研究组 & 干预措施
Zanzalintinib
Experimental
Participants will receive zanzalintinib once daily (QD).
干预措施: Zanzalintinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR)
时间窗: Up to approximately 12 months
次要结局
- Progression-free Survival at 6 Months (PFS-6) per RANO as Assessed by BICR and Investigator(Up to 6 months)
- Duration of Response (DOR) per RANO as Assessed by BICR and Investigator(Up to approximately 48 months)
- Progression-free Survival (PFS) per RANO as Assessed by BICR and Investigator(Up to approximately 48 months)
- Overall Survival (OS)(Up to approximately 48 months)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to approximately 48 months)
- Change from Baseline in Neurologic Function as Measured by the Neurologic Assessment in Neuro-oncology (NANO) Scale Score(Baseline up to approximately 13 months)
- Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L) Score(Baseline up to approximately 13 months)
研究者
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