NCT03789656已完成2 期
An Open Label Exploratory Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly Treated With Somatostatin Analogue Based Treatment Regimens (ACROBAT Edge)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 26
- 主要终点
- Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level
研究概览
简要总结
An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.
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
- •Male and female subjects 18 to 75 years of age
- •Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
- •Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
- •Willing to provide signed informed consent
排除标准
- •Treatment naïve acromegaly subjects
- •Prior treatment with paltusotine
- •Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.
- •History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
- •Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
- •Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
- •History of alcohol or substance abuse in the past 12 months
- •Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
- •Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
- •Subjects with symptomatic cholelithiasis
- •Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
- •Subjects taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg
- •Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
研究组 & 干预措施
Paltusotine
Experimental
干预措施: Paltusotine (Drug)
结局指标
主要结局
Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level
时间窗: 13 Weeks
Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).
次要结局
- Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)(13 Weeks)
- Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN(13 Weeks)
研究者
研究点 (26)
Loading locations...
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