Neuropathic Pain in Patients With Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Neuropathic Pain

In brief

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.

Key facts

Study ID

NCT00474916

Run by

DARA Therapeutics

People needed

19

Starts

2006-06-01

Expected to finish

2009-04-01

Last updated by the study team

2010-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cancer Institute Medical Group — Los Angeles, California, United States
• Ghassan Al-Jazayrly, M.D., Inc. — Los Angeles, California, United States
• University of California / Irvine Chao Family Comprehensive Cancer Center — Orange, California, United States
• Keog Pharma, Inc. — Jupiter, Florida, United States
• Hematology and Oncology Specialists, LLC — Covington, Louisiana, United States
• St. Agnes Healthcare, Inc — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• East Orange VA Medical Center — East Orange, New Jersey, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Carolina Pain Institute, PA — Winston-Salem, North Carolina, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Dr. Rivera-Colon — Rio Piedras, Puerto Rico

Full record on ClinicalTrials.gov

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