Neuropathic Pain in Patients With Cancer

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DARA Therapeutics
• Treatments: KRN 5500

Criteria

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