NCT04837040终止3 期
A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 39
- 主要终点
- Percentage of Participants Who Maintain Biochemical Response in IGF-1 (≤1.0× the Upper Limit of Normal [ULN]) at the End of the Randomized Control Phase (EOR)
研究概览
简要总结
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
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
- Double (Participant, 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
- •Male and female subjects ≥18 years of age
- •Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
- •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- •Treatment naïve or treatment-withdrawn acromegaly subjects
- •Prior treatment with paltusotine
- •Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy
- •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
- •Known history of HIV, hepatitis B, or active hepatitis C
- •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, or 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 currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Paltusotine
Experimental
干预措施: Paltusotine (Drug)
结局指标
主要结局
Percentage of Participants Who Maintain Biochemical Response in IGF-1 (≤1.0× the Upper Limit of Normal [ULN]) at the End of the Randomized Control Phase (EOR)
时间窗: 36 Weeks
A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements (weeks 34 and 36).
次要结局
- Change From Baseline in IGF-1 to EOR(Baseline to 36 Weeks)
- Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOR(Baseline to 36 Weeks)
- Change From Baseline in IGF-1 to EOR(Baseline to 36 Weeks)
- Percentage of Participants With GH <1.0 ng/mL at Week 34(Week 34)
- Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOR(Baseline to 36 Weeks)
研究者
研究点 (39)
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