A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 12
- 主要终点
- 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."
研究概览
简要总结
The purpose of this study is to collect beginning information on whether intravenous (IV) administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients with cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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
排除标准
- •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
研究组 & 干预措施
KRN5500
KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline
干预措施: KRN5500 (Drug)
Normal Saline
Placebo consists of IV infusion of normal saline
干预措施: KRN5500 (Drug)
Normal Saline
Placebo consists of IV infusion of normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
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."
时间窗: Weekly for 10 weeks plus 30 day followup
次要结局
- 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(Weekly for 10 weeks plus 30 day followup)