NCT00092287终止3 期
A Phase III, Prospective, Multicenter, Randomized, Open, Parallel Group Comparison of Lanreotide Autogel® (90 and 120 mg) Administered by Deep Subcutaneous Injection Every Four Weeks, With Sandostatin LAR Depot (20 and 30 mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Target symptom frequency (flushing or stool frequency).
研究概览
简要总结
The aim of this study is to compare the efficacy and safety of lanreotide Autogel and Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce a similar clinical response in patients with carcinoid syndrome.
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
- •Histologically confirmed diagnosis of a neuroendocrine tumor of the carcinoid type.
- •Documented evidence of carcinoid syndrome (flushing and/or diarrhea) attributable to a primary tumor of the lung, stomach or mid-gut.
- •Previous positive Octreoscan.
- •World Health Organization (WHO) performance score lower than
- •At the baseline visit patients MUST satisfy the following criteria before they are randomized to receive study treatment:
- •Stool and/or flushing frequency of greater than or equal to 3 episodes/day (average over a minimum five consecutive days).
- •Patients who have previously been treated with somatostatin analogues must have discontinued treatment for a sufficient period of time (a washout period of at least 7 days for immediate release formulations and up to 2 months for prolonged release formulations is usually required). Compared with their "controlled" state on treatment, these patients must show a clinically significant deterioration (at least two episodes) of either symptom. For example, a patient considered to be controlled on their previous treatment with an estimated stool frequency of two episodes per day, must achieve a stool frequency of at least four episodes per day (average over a minimum five consecutive days).
- •WHO performance score lower than 2.
排除标准
- •VIPoma or other non-carcinoid tumor.
- •Treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to inclusion, or planned during the study.
- •Radionuclide treatment within three months prior to inclusion, or planned during the study.
- •Presence of other active malignant pathology (except basal cellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus).
- •Surgical procedure or embolization procedure (with or without cytotoxic agents) of the tumor within three months prior to inclusion, or planned during the study.
- •Life expectancy of less than 6 months.
- •Any investigational drug given within 30 days prior to inclusion or expected to be given during the study.
- •No access to a telephone for completion of the daily telephone diary.
结局指标
主要结局
Target symptom frequency (flushing or stool frequency).
次要结局
未报告次要终点
研究者
研究点 (2)
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