NCT04151719撤回3 期
An Open-Label Extension Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Overall Survival
研究概览
简要总结
This open-label extension study will evaluate the long-term safety and efficacy of oral MNTX in participants with advanced pancreatic cancer (adenocarcinoma) who were previously enrolled in Study SAL-REL-2042 (NCT04083651).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants greater than or equal to (≥)18 years of age on the date the Informed Consent Form (ICF) is signed, with the capacity to provide voluntary informed consent.
- •Enrolled in double-blind Study SAL-REL-2042 (NCT04083651) and completed an end of study (EOS) visit (Day 168) or completed Day 56 of the Study SAL-REL-2042 (NCT04083651).
- •Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)-approved ICF and provide authorization, as appropriate, for local privacy regulations.
- •Willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.
- •Signed an informed consent/Health Insurance Portability and Accountability Act (HIPAA) form.
排除标准
- •Concurrent therapy with any other investigational agent during the study.
- •Current use of a peripherally acting mu-opioid-receptor antagonist.
- •Current evidence of untreated brain metastasis(es).
- •Diarrhea greater than Grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
- •Bowel obstruction.
- •Advanced liver disease.
- •Renal disease.
- •Any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Principal Investigator, would make the participant inappropriate for the study.
研究组 & 干预措施
MNTX 450 mg QD
Experimental
Participants will receive methylnaltrexone bromide (MNTX) 450 milligrams (mg) (3 tablets of 150 mg each) once daily (QD) orally. Treatment will continue until participant's death or early withdrawal from the study or study termination by the sponsor.
干预措施: Methylnaltrexone bromide (MNTX) (Drug)
结局指标
主要结局
Overall Survival
时间窗: From first MNTX dose administration until death from any cause (up to 4 years)
次要结局
未报告次要终点
研究者
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