NCT06943755招募中2 期
A Phase 2/3, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Exelixis
- 入组人数
- 440
- 试验地点
- 136
- 主要终点
- Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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, locally advanced/unresectable or metastatic, well-differentiated Grade 1, 2, or 3 NETs of pancreatic origin or extra-pancreatic origin.
- •Allowed prior lines of therapy, based on the site of NET and functional status.
- •Documented radiographic disease progression per RECIST 1.1, as assessed by the Investigator based on imaging assessments (computed tomography [CT] or magnetic resonance imaging [MRI]) within 12 months before randomization.
- •Measurable disease according to RECIST 1.1 as determined by the Investigator.
- •Archival tumor tissue is required, if available. If archival tumor tissue is not available, a fresh biopsy may be submitted if it can be safely and feasibly obtained. Every attempt should be made to provide tumor tissue.
排除标准
- •Histologically confirmed neuroendocrine carcinomas (including small cell lung cancer), medullary thyroid cancer, pheochromocytoma, paraganglioma, Merkel cell carcinoma, and mixed neuroendocrine non-neuroendocrine neoplasm (MiNEN).
- •Prior treatment with a vascular endothelial growth factor receptor (VEGFR) -targeting tyrosine kinase inhibitor or a mammalian target of rapamycin (mTOR) inhibitor.
- •Systemic chemotherapy and any liver-directed or other ablative therapy within 4 weeks before randomization.
- •Systemic radionuclide therapy within 6 weeks before randomization.
- •Radiation therapy for bone metastases within 2 weeks, any other radiation therapy, except as indicated above, within 4 weeks before randomization.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Zanzalintinib
Experimental
Participants will receive zanzalintinib oral tablets once daily.
干预措施: Zanzalintinib (Drug)
Everolimus
Active Comparator
Participants will receive everolimus oral tablets once daily.
干预措施: Everolimus (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
时间窗: Up to 48 months
次要结局
- PFS Per RECIST 1.1 as Assessed by Investigator(Up to 48 months)
- Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR and Investigator(Up to 48 months)
- Overall Survival (OS)(Up to 60 months)
- Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR and Investigator(Up to 48 months)
- Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR and Investigator(Up to 48 months)
- Change From Baseline in Participant-Reported Global Health Status (GHS) and Disease-Related Symptoms as Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score(Up to 48 months)
- Change From Baseline in Participant-Reported GHS and Disease-Related Symptoms as Assessed by EORTC Gastrointestinal Neuroendocrine Tumor module (QLQ-GI.NET21) Score(Up to 48 months)
- Number of Participants With Adverse Events(Up to 48 months)
研究者
研究点 (136)
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