Weinstein, S.M., Abernethy, A.P., Spruill, S.E., Pike, I.M., Kelly, A.T., & Jett, L.G. (2012). A spicamycin derivative (KRN5500) provides neuropathic pain relief in patients with advanced cancer: A placebo-controlled, proof-of-concept trial. Journal of Pain and Symptom Management, 43, 679–693.doi: 10.1016/j.jpainsymman.2011.05.003
To evaluate the safety and efficacy of KRN5500 for refractory neuropathic pain in patients with advanced cancer
KRN5500 is an agent that inhibits certain enzymes that may modulate aspects of neuropathic pain. Patients were randomly assigned to receive up to 8 weekly doses of the study drug or placebo. Patients were followed over 14 weeks. Patients were allowed to continue their usual pain treatments. KRN5500 was given in escalating IV doses ranging from 0.6–2.2 mg/m2. Study assessments were done at baseline, during weekly clinic visits, and at the end of 14 weeks.
This was a multisite, outpatient study conducted in the United States and Puerto Rico.
This was a double-blind, randomized, placebo-controlled, dose-finding trial.
This study provided some initial information regarding safety and efficacy of KRN5500 in a small cohort of patients.
The sample size was small, with fewer than 30 patients.
No conclusions can be drawn regarding the overall safety and efficacy of this drug. Further research in this area is needed.