Phase II, Open, Adaptive, Dose Escalating, Multicentre Titration Study to Assess the Efficacy and Safety of Repeated Subcutaneous Administration of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 8
- 试验地点
- 54
- 主要终点
- Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale
研究概览
简要总结
The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a carcinoid syndrome defined as ≥3 stools/day and/or ≥3 flushes/week.
- •The patient has elevated 5-Hydroxyindoleacetic acid (above upper limit normal).
- •The patient has a well-differentiated mid-gut carcinoid tumour or serotonin secreting tumour of unknown localisation with hepatic metastasis.
排除标准
- •The patient has undergone surgery related to a neuroendocrine tumour (NET) within 4 weeks prior to study entry or has surgery planned during the study.
- •The patient has received short acting somatostatin analogues (SSAs) within 2 weeks before study entry or has received short acting SSAs for more than 3 months.
- •The patient has received a radiolabelled SSA at any time before study entry.
- •The patient has received long acting SSAs under certain circumstances.
- •The patient has previously received any specific anti tumour treatment such as chemotherapy, (chemo)embolisation, radiotherapy or interferon in the last 6 months.
- •The patient has signs or symptoms of cardiac insufficiency.
- •The patient has an ejection fraction <40% and/or clinically severe cardiac valvular regurgitation.
研究组 & 干预措施
BIM 23A760
This dose adaptive study is planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed are 1, 2, 4, 6 and 8 mg, however, the maximum starting dose will be 4 mg. The starting dose of the first cohort will be 1 mg; the first cohort will include at least five patients. After the first fifteen patients have been treated for 4 weeks, the results will be reviewed by a Data Review Committee. An extension phase (Part B) is planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).
干预措施: BIM 23A760 (Drug)
结局指标
主要结局
Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale
时间窗: Week 24
Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)
次要结局
- Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels(At 8 timepoints up to week 24)
- Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)(Up to week 24)
- Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A(Week 24)
- Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)(Up to week 26)
- Change in the Quality of Life (QoL) Assessment(Week 24)
- Minimum Concentration (Cmin) BIM 23A760 Plasma Levels(At 9 timepoints up to 1 week after 24th administration in week 24)