A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-related Symptoms Are Inadequately Controlled by Somatostatin Analogues.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 11
- 主要终点
- Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.
研究概览
简要总结
The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
研究组 & 干预措施
Pasireotide LAR
Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
干预措施: Pasireotide (Drug)
Octreotide LAR
Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
干预措施: Octreotide (Drug)
结局指标
主要结局
Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.
时间窗: Month 6
Percentage of patients who received clinical benefit in symptom (diarrhea and/or flushing) improvement as: Diarrhea (D)+Flushing (F): Patients with a daily mean number (#) of at least four bowel movements and a total of five or more flushing episodes. Clinical Benefit Response Criteria (CBRC): \<4 daily mean bowel movements AND at least 20% reduction from Baseline in the daily mean # of bowel movements AND any reduction in the total # of flushing episodes compared with Baseline. (D) Patients with a daily mean # of at least four bowel movements and a total # of \<5 flushing episodes. (CBRC) \<4 daily mean bowel movements AND at least a 20% reduction from Baseline in the daily mean # of bowel movements. (F) Patients with a total # of at least 14 flushing episodes and a daily mean # of \<4 bowel movements (CBRC) At least a 30% reduction from Baseline in the total # of flushing episodes.
次要结局
- Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.(6 months)
- Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.(6 months)
- Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response.(Month 6)
- Objective Tumor Response Rate Assessed by Investigator(Month 6)
- Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria(Month 6)
- Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire(Month 6)
- Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression(Month 6)
- Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response(Month 6)
- Assess the Proportion of Patients Who Achieved at Least a 30% Reduction in Frequency of Bowel Movements(Month 6)