Neuropathic Pain in Patients With Cancer
A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer
研究概览
详细说明
Neuropathic pain is a type of pain that results from nerve damage and is characterized by an abnormal hypersensitivity to harmless as well as harmful stimuli. This type of pain is extremely difficult to manage, fails to respond to standard analgesic medications or interventions, and often gets worse instead of better over time. Current approved therapeutic agents often have intolerable side effects and limited efficacy. Thus, there is an urgent need to develop safe and effective drugs to treat neuropathic pain.
Study DTCL100 will be conducted at multiple centers and will enroll patients that have advanced cancer AND neuropathic pain that has not responded well to previous treatment. Eighteen patients will be randomly assigned to receive up to 8 doses of active drug (KRN5500) or placebo. A maximum of 8 doses will be administered weekly over a 10 week period. Patients are encouraged to complete at least 4 treatment visits before a decision is made to complete the full 10 weeks of treatment and the 1 month followup period.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Rio Piedras、波多黎各、00921
- Dr. Rivera-Colon
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California
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Los Angeles、California、美国、90025
- Cancer Institute Medical Group
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Los Angeles、California、美国、90027
- Ghassan Al-Jazayrly, M.D., Inc.
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Orange、California、美国、92868
- University of California / Irvine Chao Family Comprehensive Cancer Center
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Florida
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Jupiter、Florida、美国、33477
- Keog Pharma, Inc.
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Louisiana
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Covington、Louisiana、美国、70433
- Hematology And Oncology Specialists, Llc
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Maryland
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Baltimore、Maryland、美国、21229
- St. Agnes Healthcare, Inc
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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New Jersey
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East Orange、New Jersey、美国、07018
- East Orange VA Medical Center
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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Winston-Salem、North Carolina、美国、27103
- Carolina Pain Institute, PA
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Utah
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Salt Lake City、Utah、美国、84112
- Huntsman Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years or older
- Diagnosis of advanced or recurrent cancer
- No options for curative chemotherapy, but palliative chemotherapy allowed under certain conditions
- Refractory neuropathic pain rated 4 or greater on 0-10 scale and failure to respond to 2 commonly used treatments
- If taking opioids for pain, stable regimen over past week before enrolling
- Karnofsky performance status of 40 or more
- Females must be sterile or post-menopausal
Exclusion Criteria:
- Radiation to site of neuropathic pain for past 4 weeks
- Major surgery within past 2 weeks
- Liver function and other key labs outside normal parameters
- ECG showing significant abnormality
- Myocardial Infarction (heart attack) within past 6 months
- History of interstitial lung disease
- History of severe allergic reaction to drugs containing polysorbate 80
- Other investigational drug within 2 weeks or 5 half-lives (whichever is longer
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：KRN5500
KRN5500 escalating dose of .6,
1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline
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Patients are seen weekly and dosed for pain with IV medication of active drug/KRN5500 or placebo .
The dose can be escalated, from .6 mg/m2, to 1.2, 1.8, and 2.2 mg/m2.
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安慰剂比较：Normal Saline
Placebo consists of IV infusion of normal saline
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Patients are seen weekly and dosed for pain with IV medication of active drug/KRN5500 or placebo .
The dose can be escalated, from .6 mg/m2, to 1.2, 1.8, and 2.2 mg/m2.
Normal Saline given as dose escalation for placebo
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Average pain intensity over the previous 24 hours as measured by a numeric rating scale (NRS) ranging from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain."
大体时间：Weekly for 10 weeks plus 30 day followup
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Weekly for 10 weeks plus 30 day followup
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次要结果测量
结果测量 |
大体时间 |
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Physical Examination, Vital signs and body weight, Electrocardiogram, Laboratory parameters, Adverse events, Clinical Opiate Withdrawal Scale, rescue medication, Proportion of patients who achieved a 33% reduction in pain intensity
大体时间：Weekly for 10 weeks plus 30 day followup
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Weekly for 10 weeks plus 30 day followup
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合作者和调查者
调查人员
- 首席研究员：Richard Penson, MD, MRCP、Massachusetts General Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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KRN5500的临床试验
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)完全的