A Phase II, Open-label, Multicentre, Randomised Study of the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of CAM2029 in Patients With Acromegaly and Neuroendocrine Tumours (NETs) Previously Treated With Sandostatin® LAR®
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Camurus AB
- 入组人数
- 12
- 试验地点
- 10
- 主要终点
- Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.
研究概览
简要总结
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms.
详细描述
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms, treated for at least 2 months with Sandostatin LAR at doses of 10 mg, 20 mg, or 30 mg before the start of the Sandostatin LAR Last Dose Assessment Phase (Day -28).
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
- •Acromegaly:
- •Male or female patients ≥18 years of age
- •Acromegaly currently treated with Sandostatin LAR
- •Male or female patients ≥18 years of age
- •Functional, well-differentiated (Grade 1 or Grade 2) NET with symptoms of carcinoid syndrome (number of bowel movements and/or flushing)
- •Currently treated with Sandostatin LAR for symptom control
排除标准
- •Acromegaly:
- •Inadequate bone marrow function
- •Abnormal coagulation or chronic treatment with warfarin or coumarin derivates
- •Impaired liver, cardiac and/or renal function
- •Known gallbladder, bile duct disease or pancreatitis
- •Diabetes with poorly controlled blood glucose levels despite adequate therapy
- •Hypothyroidisms not adequately treated
- •Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, typical and atypical lung carcinoids, large cell neuroendocrine carcinoma and small cell carcinoma
- •Carcinoid syndrome refractory to treatment with conventional doses of somatostatin analogues (SSAs)
- •Inadequate bone marrow function
- •Abnormal coagulation or chronic treatment with warfarin or coumarin derivates
- •Impaired liver, cardiac and/or renal function
- •Known gallbladder, bile duct disease or pancreatitis
- •Short-bowel syndrome
- •Diabetics with poorly controlled blood glucose levels despite adequate therapy
- •Hypothyroidism, not adequately treated
研究组 & 干预措施
CAM2029 10 mg (NET)
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
干预措施: octreotide FluidCrystal® injection depot (Drug)
CAM2029 20 mg (NET)
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
干预措施: octreotide FluidCrystal® injection depot (Drug)
CAM2029 10 mg (Acromegaly)
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
干预措施: octreotide FluidCrystal® injection depot (Drug)
CAM2029 20 mg (Acromegaly)
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
干预措施: octreotide FluidCrystal® injection depot (Drug)
结局指标
主要结局
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.
时间窗: (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the dosing intervals (day\*ng/mL) for CAM2029 20 mg q4w and CAM2029 10 mg q2w (to estimate AUC0-28d for those patients receiving CAM2029 10 mg q2w, AUC0-14d was multiplied by a factor of 2 as an estimate of the AUC0-28d) dosing intervals
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.
时间窗: (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax
时间窗: Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)
Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over the final (Sandostatin LAR) dosing interval (ng/mL)
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC
时间窗: Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)
Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the final dosing interval (day\*ng/mL) for Sandostatin LAR.
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
时间窗: (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84; Ctrough (ng/mL). Ctrough; Concentration levels assessed prior to next injection for CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)
次要结局
- CAM2029 Effect on Growth Hormone (GH) (Acromegaly)(Day 84)
- Number of Adverse Events and Serious Adverse Events(Day -28 to Day 84)
- CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)(Day 84)