NCT05050942进行中（未招募）3 期
A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Camurus AB
- 入组人数
- 332
- 试验地点
- 174
- 主要终点
- Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female patient ≥18 years old
- •Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin
- •At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization)
- •ECOG performance status of 0 to 2
排除标准
- •Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease
- •Known central nervous system metastases
- •Consecutive treatment with long-acting SSAs for more than 6 months before randomization
- •Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR
- •Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET
- •Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening
- •Previously received radioligand therapy (PRRT) at any time
研究组 & 干预措施
Octreotide LAR or lanreotide ATG
Active Comparator
干预措施: Lanreotide ATG (Drug)
Octreotide LAR or lanreotide ATG
Active Comparator
干预措施: Octreotide LAR (Drug)
CAM2029
Experimental
干预措施: CAM2029 (Drug)
结局指标
主要结局
Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
时间窗: From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)
次要结局
- Incidence of treatment-emergent adverse events(From screening to the safety follow-up, assessed up to 6 years)
- Overall response rate(From date of randomization until disease progression, assessed up to 48 months)
- Disease control rate(From date of randomization until disease progression, assessed up to 48 months)
- PFS as assessed by local Investigators(From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months)
- Time to tumor response(From date of randomization until disease progression, assessed up to 48 months)
- Duration of response(From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months)
- Overall survival(Up to 2 years following the primary efficacy analysis)
研究者
研究点 (174)
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