Spots Global Cancer Trial Database for Neuropathic Pain in Patients With Cancer
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Trial Identification
Brief Title: Neuropathic Pain in Patients With Cancer
Official Title: A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer
Study ID: NCT00474916
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Richard Penson, MD, MRCP
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR
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