NCT00088595已完成2 期
An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
研究概览
简要总结
Study evaluating SOM230 in patients with metastatic carcinoid tumors
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy-proven metastatic carcinoid tumors
- •Patients with at least one measurable lesion (excluding bone)
- •Patients must be considered inadequately controlled while on Sandostatin LAR therapy based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as experiencing a minimum average of at least four bowel movements per day or a minimum average of at least two episodes of flushing per day
排除标准
- •Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
- •Patients who have undergone major recent surgery / surgical therapy for any cause within 1 month
- •Patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months
- •Patients with uncontrolled diabetes mellitus
- •Patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy
- •Patients who have congestive heart failure unstable angina, cardiac arrhythmia or a history of acute myocardial infarction within the three months preceding enrollment
- •Patients with chronic liver disease
- •Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control.
- •History of immunocompromise, including a positive HIV test result
- •Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving SOM230
- •Patients who have given a blood donation (of 400 mL or more) within 2 months before receiving SOM230
- •Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
- •Patients with additional active malignant disease within the last five years
研究组 & 干预措施
Pasireotide
Experimental
干预措施: Pasireotide (SOM230) (Drug)
结局指标
主要结局
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
时间窗: 15 days
Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied. Partial Symptom Control: an average of \< 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval. Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level.
次要结局
- Duration of Complete Symptom Control (Days) by Dose Class(15 days)
- Duration of Partial Symptom Control (Days) by Dose Class(up to 15 days)
- The Number of Patients (Participants) With Overall Tumor Response(At least 15 days)
- The Overall Safety and Tolerability of Pasireotide(At least 15 days)
研究者
研究点 (4)
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