Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class
研究概览
简要总结
Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have completed all four treatment regimens in the core study CSOM230B2201 (NCT00088582) and achieved biochemical control in growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels after at least one month of pasireotide administration at any of the three doses.
- •Participants who did not experience any unacceptable adverse events or tolerability issues during the core study CSOM230B2201.
排除标准
- •Participants who experienced or developed compression of the optic chiasm causing any visual field defect during the core study CSOM230B
- •Participants who required a surgical intervention for relief of any sign or symptom associated with tumor compression during the core study CSOM230B
- •Participants who experienced or developed congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation or acute myocardial infraction during the core study CSOM230B
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Pasireotide s.c. Overall
Participants received pasireotide as a daily subcutaneous (s.c) injection, every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 microgram (μg)) for as long as the participant benefited from the treatment, and there were no safety or tolerability concerns (median duration of 22.7 months).
干预措施: Pasireotide (Drug)
结局指标
主要结局
Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class
时间窗: Month 9 (Month 9 visit is at the completion of six months in this extension study)
A participant was a responder to a dose level if the mean GH level after dosing (t30, t60, t90, and t120) was below/equal to 2.5 microgram/litre (μg/L), and if the mean of IGF-1 of the two pre-dose values (t-30, t-1) was within normal limits for age-sex matched controls. If three or more of t30, t60, t90, or t120 were missing, mean GH was considered missing. If either t-30 or t-1 was missing, mean IGF-1 was considered missing. Pasireotide incident dose classes were defined by total daily doses ranges (\<1200 μg/d, 1200 to \<1500 μg/d, ≥ 1500 μg/d).
次要结局
- Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation(Core study baseline till the last assessment of the extension study (up to approximately 114 months))
- Time to Tumor Response(Core study baseline to at least a 20% decrease in pituitary tumor volume (up to approximately 114 months))
- Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes(Core study baseline, Months 9, 27, 63, 75 and 99)
- Percentage of Participants With Symptoms of Acromegaly(Core study baseline till the last assessment of the extension study (up to approximately 114 months))
- Percentage of Participants With One or More Adverse Events (AEs)(From start of study drug treatment up to end of study (approximately 111 months))