A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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
Richard Penson, MD, MRCP
Massachusetts General Hospital
United States: Food and Drug Administration
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Duke University Medical Center||Durham, North Carolina 27710|
|Hematology and Oncology Specialists, LLC||New Orleans, Louisiana 70115|
|Cancer Institute Medical Group||Los Angeles, California 90025|
|East Orange VA Medical Center||East Orange, New Jersey 07018|
|Ghassan Al-Jazayrly, M.D., Inc.||Los Angeles, California 90027|
|University of California / Irvine Chao Family Comprehensive Cancer Center||Orange, California 92868|
|Keog Pharma, Inc.||Jupiter, Florida 33477|
|St. Agnes Healthcare, Inc||Baltimore, Maryland 21229|
|Carolina Pain Institute, PA||Winston-Salem, North Carolina 27103|