Neuropathic Pain in Patients With Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Drug: KRN5500
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KRN5500<br>KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline | Drug: KRN5500<br>* 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.<br>|
| Placebo Comparator: Normal Saline<br>Placebo consists of IV infusion of normal saline | Drug: KRN5500<br>* 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.<br>Drug: Placebo<br>* Normal Saline given as dose escalation for placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Weekly for 10 weeks plus 30 day followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain, Cancer