NCT01590199已完成1 期
Extension Study to the "Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study"
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
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability
研究概览
简要总结
This study will evaluate long-term safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic NET patients, who who have not progressed during 12 months of combination therapy with pasireotide LAR and everolimus
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- •Patients eligible for inclusion in this extension study have to meet all of the additional inclusion criteria:
- •The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures
- •Completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide LAR or everolimus followed by a 12 months combination of pasireotide LAR/everolimus) in the CSOM230F2102 study
- •No tumor progression during 12 months of combination therapy with pasireotide LAR and everolimus (checked via radiologically assessment).
- •No intolerable toxicity during combination therapy with pasireotide LAR and everolimus
研究组 & 干预措施
RAD001 + SOM230
Experimental
干预措施: RAD001 (Drug)
RAD001 + SOM230
Experimental
干预措施: SOM230 (Drug)
结局指标
主要结局
Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability
时间窗: up to 4 years
Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability
时间窗: up to 4 years
次要结局
- best overall response(up to 4 years)
- investigator-assessed progression free survival (PFS)(up to 4 years)
研究者
研究点 (1)
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