A Phase II, Randomized, Single Center, Pilot Feasibility Study to Evaluate Naloxegol for Opioid-Induced Constipation in Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care
研究概览
简要总结
The purpose of this study is to compare the effect of naloxegol versus the patient's usual care in treating opioid-induced constipation, as well as the effect on the patient's quality of life and how much pain is experienced. Also, the purpose of this study is to compare whether treatment with naloxegol versus usual care has any impact on the number of hospital or clinic visits or telephone calls to the patient's physician that are related to constipation, and to determine the patient's preference for continuing to receive naloxegol as treatment for opioid-induced constipation.
详细描述
Opioid-induced constipation (OIC) is a common symptom in patients with cancer-related pain and requires burdensome self-titration of laxatives for prophylaxis and treatment. Consequently, naloxegol may have an important role in this setting. Naloxegol has been evaluated in relieving OIC with cancer patients in a randomized, double blind, placebo-controlled trial over 4 weeks with a 12-week extension phase. However, accrual was challenging and the trial was closed early. Given the complexity of cancer and its treatment, a key first step is to determine if evaluating naloxegol versus standard of care is feasible in the management of OIC in this setting.
Subjects will receive naloxegol 25mg daily or usual care for a 2-week initial treatment period followed by 3-day washout period, then a 2-week crossover treatment period where subjects will receive naloxegol or usual care. Treatment assignment during the initial and crossover treatment periods will be dictated by the randomization arm. Subjects will also have the option to participate in a 12-week extension phase of naloxegol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Adults greater than or equal to 18 years old.
- •Eastern Cooperative Oncology Group (ECOG) less than or equal to
- •Glomerular filtration rate (GFR) greater than or equal to 30 ml/min/1.73m2 by Modification of Diet in Renal Disease (MDRD).
- •Corrected serum calcium level less than or equal to 10.5 mg/dL.
- •Estimated life expectancy greater than or equal to 6 months.
- •Negative pregnancy test prior to initiating study treatment for females of childbearing potential.
排除标准
- •Patients receiving the following medications within 3 days of Study Day 1 and/or are planned to receive throughout the duration of the study period: opioid antagonist, mixed antagonist, a strong CYP3A4 and/or P-glycoprotein (P-gp) inhibitor, a moderate CYP3A4 and/or P-gp inhibitor, and/or a strong CYP3A4 inducer.
- •Concurrent total parenteral nutrition and/or use of metoclopramide.
- •Patients at high risk for bowel perforation.
- •Constipation that was not primarily caused by opioids in the investigator's medical opinion.
- •A condition that may have affected the permeability of the blood-brain barrier (e.g., known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent brain injury, uncontrolled epilepsy)
- •Patient has clinically active diverticular disease.
- •Past medical history of irritable bowel syndrome, signs of active gastrointestinal (GI) bleeding, acute surgical abdomen, bowel stents, indwelling peritoneal catheter, mechanical GI obstruction, fecal impaction, or fecal ostomy.
- •Patient has motility/neurologic disorders including autonomic failure (spinal cord lesions, tumor invasion of nerves) and/or poorly controlled endocrine/metabolic disorders (hypercalcemia, hypokalemia, diabetes, hypothyroidism), as determined by the investigator.
- •Uncontrolled cancer pain despite analgesic therapy
研究组 & 干预措施
A
Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.
干预措施: naloxegol (Drug)
B
Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.
干预措施: naloxegol (Drug)
结局指标
主要结局
Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care
时间窗: 4 weeks
completion of treatment defined as participants receiving all single daily doses for 2 weeks
次要结局
未报告次要终点
研究者
Joseph Ma
Associate Clinical Professor
University of California, San Diego