SKandF107647: A synthetic hematoregulatory peptide in patients with solid tumor malignancies A phase I trial

John Nemunaitis, David E. Martin, Deborah L. Willis, Martin I. Freed, Blanche Levitt, Donald A. Richards, John V. Cox, Gary T. Kimmel, William J. Hyman, Diane K. Jorkasky

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

SKandF107647 is a synthetic hematoregulatory peptide (HP) increases both the number and function of progenitor cells, enabling improved survival after lethal myelosuppression, lethal fungal infection, and lethal herpes simplex virus infection in murine models. This Phase I single-blind placebocontrolled dose-rising crossover trial examined the efficacy of SKandF107647 in patients who had incurable solid tumor malignancies. Sixteen patients were treated. Six adverse events in 3 patients were considered to be possibly related to SKandF107647; all were mild to moderate in nature (mild nervousness and agitation at 0.01 ng/kg, moderate fever and mild nausea at 0.1 ng/kg, elevated hepatic enzymes at 0.1 ng/kg, and mild vomiting at 1.0 ng/kg). Plasma half-life was 2.44 hours (±1.07 standard deviation). The observed area volume of distribution was 16.7 L (±7.7 standard deviation) and clearance was 5.04 L/hour (±1.83 standard deviation). When administered as a single 2-hour intravenous infusion at doses ranging from 0.01 to 100 ng/kg, SKandF107647 is safe and well tolerated.

Original languageEnglish (US)
Pages (from-to)189-194
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume21
Issue number2
DOIs
StatePublished - Apr 1 1998

Keywords

  • Hematoregulatory peptide
  • SKandF107647

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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