NL-OMON29869尚未招募2 期
An open label, stratified, single-arm phase II study of RAD001 in patients with advanced pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy - Phase II study in patients with pancreas NET
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- ovartis
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Advanced (unresectable or metastatic) biopsy-proven pancreatic neuroendocrine tumor.
- •* Pancreatic neuroendocrine tumor with documented objective progression of disease while receiving cytotoxic chemotherapy or documented progression at any time after receiving an adequate course of cytotoxic chemotherapy
- •* At screening a CT or MRI scan must demonstrate measurable disease
- •* Adequate liver function: bilirubin <= 1.5 x ULN; ALT and AST <= 2.5x ULN ( <= 5x ULN in patients with liver metastases).
- •* Stratum 1: Not receiving Sandostatin LAR <= 30 days of enrollment
- •* Stratum 2 only: receiving treatment (at least 3 consecutive months) with Sandostatin LAR Depot.
排除标准
- •* Anticancer therapy within 3 weeks of enrollment
- •* Hepatic artery embolization within the last 6 months, or cryoablation of hepatic metastasis within 2 months of enrollment.
- •* Prior therapy with RAD001 (everolimus) or other rapamycins
- •* Uncontrolled diabetes
- •* Chronic active or persistent liver disease
研究者
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