NCT01364415已完成1 期
A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs
研究概览
简要总结
This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.
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
- •≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma
- •unresectable metastatic NET tumor with measurable disease
- •life expectancy ≥ 12 weeks
排除标准
- •Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
- •patients with known hypersensitivity to somatostatin analogs
- •patients with symptomatic cholelithiasis in the past 2 months
- •patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix
- •patients with known history of hepatitis C or chronic active hepatitis B
- •patients with diagnosis of HIV.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Pasireotide LAR
Experimental
干预措施: Pasireotide LAR (Drug)
结局指标
主要结局
Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs
时间窗: Sequentiona 56 day cohorts until the MTD is determined
Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.
次要结局
- assess the pharmacodynamics (PD) of pasireotide LAR(minimum of twelve 28 day cycles to approximately eighteen 28 day cycles)
- assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR.(minimum of twelve 28 day cycles to approximately eighteen 28 day cycles)
- assess the safety and tolerability of pasireotide LAR(minimum of twelve 28 day cycles to approximately eighteen 28 day cycles)
- assess the pharmacokinetics (PK) of pasireotide LAR(minimum of twelve 28 day cycles to approximately eighteen 28 day cycles)
研究者
研究点 (4)
Loading locations...
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