Neuropathic Pain
Conditions
Keywords
Neuropathic pain, Cancer
Brief summary
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
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.
Interventions
DRUGKRN5500
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.
DRUGPlacebo
Normal Saline given as dose escalation for placebo
Sponsors
DARA Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Puerto Rico, United States
Outcome results
None listed