NCT03226574已完成1 期
A Multicenter, Open-Label, Phase 1b Study to Assess the Safety and Define the Maximally Tolerated Dose of Epidural Resiniferatoxin Injection for the Treatment of Intractable Pain Associated With Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
The study is a multicenter, open-label Phase 1b single dose escalation safety study for adult subjects with intractable pain associated with cancer in any area below the mid-thoracic level who meet all other eligibility criteria.
详细描述
All subjects who received RTX will be included in the analyses and summaries of safety, efficacy, PD, and PK assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Histologically confirmed advanced cancer or metastasis, which has not responded to standard therapy, producing intractable chronic pain in any area below the mid-thoracic level.
- •Male or female subjects must be at least 18 years of age.
- •Must have a worst pain score ≥6 on the NPRS at Screening visit.
- •Subjects not seeking or receiving potentially curative therapies for cancer. Palliative therapy is acceptable if the therapy started and is stable prior to IP administration.
- •Sexually active female subjects of childbearing potential and male subjects capable of fathering a child must be willing to use an effective method of contraception to avoid pregnancies.
- •Must be willing and capable of understanding and cooperating with the requirements of the study.
- •Must be able to understand and complete study-related forms and adequately communicate with the investigator and/or site staff.
- •Must have provided written informed consent prior to participating in any study-related activity.
- •Subjects able to complete the study duration.
排除标准
- •Subjects with leptomeningeal metastases in lumbar area.
- •Undergoing or have plans to undergo changes to current cancer treatment during the study through the Day15 assessment.
- •Had prior lumbar spine surgical procedures that could impair the ability to perform the injection.
- •Evidence of brain pathology or increase intracranial pressure.
- •Presence of an IT shunt.
- •Has evidence or a coagulopathy or hemostasis problem.
- •Subjects with a total neutrophil count <1500 cells/mm
- •Subjects with serum creatinine ≥1.5 mg/dL.
- •Is febrile or has other evidence of an infection within 7 days of planned injection.
- •Has an allergy or hypersensitivity to chili peppers, capsaicin, or radiographic contrast agents.
- •Female subjects who are pregnant, are planning on becoming pregnant, or are currently breastfeeding.
- •Subjects with any medical condition that could adversely impact study participation or assessments.
- •Subjects who have received new anti-cancer treatments and there is less than one week or four half-lives of the investigational drug, whichever is greater, between the last dose of the new drug and the planned day of IP administration; or had a change in the dose or schedule of the anti-cancer treatments within one week or four half-lives, whichever is greater, between the last dose of the anti-cancer treatment and the planned day of IP administration; or are scheduled to receive a new anti-cancer therapy or investigational product prior to completion of the Day 15 visit.
- •Subjects with additional loci of pain above the mid-thoracic level or other pain disorder due to non-cancer etiology, unless both the investigator and the subject are clearly able to distinguish the additional pain from the target pain due to cancer.
- •Liver cirrhosis or severe hepatic impairment, with liver function test 3 times above ULN.
- •Sensory/peripheral neuropathy of CTCAE Grade 2 or higher.
- •Nonstudy related minor surgical procedure ≤5 days or major surgical procedure ≤21 days prior to Screening visit.
- •Subjects who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies that are CTCAE Grade 3 or higher.
- •Arterial thrombi (including stroke), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within 3 months prior to Screening visit.
- •Corrected QT using Fridericia's formula (QTcF) prolongation.
- •Evidence or history of bleeding disorder within 4 weeks prior to IP administration.
- •Known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C.
研究组 & 干预措施
RTX epidural injection
Experimental
Epidural injection of 1.5mL/min RTX under the guidance of epidurogram.
干预措施: Resiniferatoxin (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 3-month
Grade 3 or 4 Toxicity associated with RTX administration
Maximum tolerated dose (MTD)
时间窗: 3-month
Maximum dose without a Grade 3 or 4 toxicity
次要结局
- Numeric Pain Rating Scale (NPRS)(Day-28 to Day90 daily)
研究者
研究点 (4)
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