An Open-label, Two-step, Multicenter European Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Not Adequately Controlled by Conventional Regimen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The Percentage of Participants With Complete Response (CR) at 8 Months
研究概览
简要总结
This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at conventional regimen.
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
- •Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender)
- •Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25% from any medical pretreatment level
- •Patient currently receiving somatostatin-analogues at conventional regimen (maximum registered dose) for at least 6 months before inclusion
排除标准
- •Newly diagnosed or previously medically untreated acromegalic patient
- •Concomitant treatment with GH-receptor antagonist
- •Concomitant treatment with dopamine-agonist
- •Symptomatic cholelithiasis or choledocolithiasis
- •Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according to local laboratory)
- •Previous gamma-knife radiotherapy for treatment of acromegaly
- •Compression of the optic chiasm causing visual field defect
- •Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all drugs
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Sandostatin LAR high dose Alone
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
干预措施: Sandostatin LAR (Drug)
Sandostatin LAR high dose + Pegvisomat
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR40 mg every 28 days in combination with weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months
干预措施: Sandostatin LAR (Drug)
Sandostatin LAR high dose + Pegvisomat
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR40 mg every 28 days in combination with weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months
干预措施: pegvisomant (Drug)
Sandostatin LAR high dose + Cabergoline
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR 40 mg every 28 days in combination with weekly cabergoline for a further 4 months, with cabergoline doses as follows:
- st week: 0.25 mg twice a week (0.50 mg/week)
- nd week: 0.50 mg/week twice a week (1 mg/week)
- rd week: 0.50 mg four times a week (2 mg/week)
- th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)
干预措施: Sandostatin LAR (Drug)
Sandostatin LAR high dose + Cabergoline
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR 40 mg every 28 days in combination with weekly cabergoline for a further 4 months, with cabergoline doses as follows:
- st week: 0.25 mg twice a week (0.50 mg/week)
- nd week: 0.50 mg/week twice a week (1 mg/week)
- rd week: 0.50 mg four times a week (2 mg/week)
- th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)
干预措施: cabergoline (Drug)
结局指标
主要结局
The Percentage of Participants With Complete Response (CR) at 8 Months
时间窗: From Baseline to 8 months
A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment: * Mean 1 hour GH \< 2.5µg/L (according to Central Laboratory); and * IGF-I within the Central Laboratory Normal Range (for age and gender).
次要结局
- The Percentage of Participants With Partial Response (PR) at 8 Months(From Baseline to 8 months)
- The Percentage of Participants With Complete Response (CR) At 3 Months(From Baseline to 3 months)