Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy, Low-Dose SRL + Weekly Pegvisomant Therapy, and High-Dose SRL + Weekly Pegvisomant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Cost Effectiveness
研究概览
简要总结
In this study the investigators will evaluate whether combination low dose somatostatin receptor ligand (SRL) and weekly or daily pegvisomant will attain equivalent control of serum insulin-like growth factor (IGF)-1 levels at a lower cost, compared to combination high dose SRL and weekly pegvisomant. Lower doses of therapy will greatly reduce cost of acromegaly therapy.
详细描述
Subjects will be stratified based on prior response to SRL therapy and then randomized to one of three treatment arms. The study will begin when the combination of octreotide long-acting release (LAR) or lanreotide and pegvisomant is first administered. Study visits will occur every 4 weeks from the start of the study. However, for subjects who cannot make every study visit due to distance, the study team will facilitate monthly blood draws at their local Quest laboratory facility.
After the 24 weeks of combination therapy, subjects with a controlled IGF-1 will then start pegvisomant monotherapy at the same dose and schedule that they attained normalization in combination therapy. IGF-1 levels, liver function test, and blood glucose will be performed monthly. Magnetic resonance imaging (MRI) will be performed at the conclusion of the study.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with acromegaly who have not had surgery or medical therapy
- •Acromegaly patients who are at least 3 months post surgery, who are/are not receiving adjuvant medical therapy
- •Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels
- •Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels.
- •Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week washout period of the dopamine agonist.
- •Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant (daily or weekly
- •Normal liver function tests before randomization to treatment
- •The patient has had appropriate dynamic testing of the pituitary axis and, if applicable, is receiving appropriate hormone replacement therapy.
排除标准
- •The patient harbors a macroadenoma with visual field defects due to chiasmatic compression
- •The patient has clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit of normal at the baseline visit.
- •The patient had pituitary surgery within 3 months prior to study entry
- •The patient had radiotherapy within 12 months prior to study entry
- •The patient has abnormal CBC and chemistry panel at the baseline visit, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety.
- •The patient has a known hypersensitivity to any of the test materials or related compounds.
- •The patient has a history of, or known current problems with alcohol or drug abuse.
- •The patient has any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
研究组 & 干预措施
Low dose SRL + daily Pegvisomant
Low dose of SRL monthly
- Octreotide LAR 10mg
- Lanreotide 60mg
Daily Pegvisomant (15-60mg/day)
干预措施: Pegvisomant (Drug)
Low dose SRL + daily Pegvisomant
Low dose of SRL monthly
- Octreotide LAR 10mg
- Lanreotide 60mg
Daily Pegvisomant (15-60mg/day)
干预措施: Octreotide LAR (Drug)
High dose SRL + weekly Pegvisomant
High dose of SRL monthly
- Octreotide LAR 30mg
- Lanreotide 120mg
Weekly Pegvisomant (40-120mg/week)
干预措施: Pegvisomant (Drug)
High dose SRL + weekly Pegvisomant
High dose of SRL monthly
- Octreotide LAR 30mg
- Lanreotide 120mg
Weekly Pegvisomant (40-120mg/week)
干预措施: Octreotide LAR (Drug)
High dose SRL + weekly Pegvisomant
High dose of SRL monthly
- Octreotide LAR 30mg
- Lanreotide 120mg
Weekly Pegvisomant (40-120mg/week)
干预措施: Lanreotide (Drug)
Low dose SRL + daily Pegvisomant
Low dose of SRL monthly
- Octreotide LAR 10mg
- Lanreotide 60mg
Daily Pegvisomant (15-60mg/day)
干预措施: Lanreotide (Drug)
Low dose SRL + weekly Pegvisomant
Low dose of SRL monthly
- Octreotide LAR 10mg
- Lanreotide 60mg
Weekly Pegvisomant (40-120mg/week)
干预措施: Pegvisomant (Drug)
Low dose SRL + weekly Pegvisomant
Low dose of SRL monthly
- Octreotide LAR 10mg
- Lanreotide 60mg
Weekly Pegvisomant (40-120mg/week)
干预措施: Octreotide LAR (Drug)
Low dose SRL + weekly Pegvisomant
Low dose of SRL monthly
- Octreotide LAR 10mg
- Lanreotide 60mg
Weekly Pegvisomant (40-120mg/week)
干预措施: Lanreotide (Drug)
结局指标
主要结局
Cost Effectiveness
时间窗: 24 weeks
We evaluated cost-effectiveness of combination low-dose SRL and weekly or daily pegvisomant compared to combination high-dose SRL and weekly pegvisomant by assessing cost of therapy per month in each treatment arm among patients who achieved normal IGF-1 levels.
次要结局
未报告次要终点
研究者
Shlomo Melmed, MD
Executive Vice President, Academic Affairs
Cedars-Sinai Medical Center