Phase I and pharmacologic study of PN401 and fluorouracil in patients with advanced solid malignancies
Academic Article
Overview
MeSH Major
Antimetabolites, Antineoplastic
Fluorouracil
Hematologic Diseases
Prodrugs
Uridine
abstract
Treatment with oral PN401 beginning 8 hours after 5-FU administration is well tolerated and results in sustained plasma uridine concentrations above therapeutic-relevant levels. The recommended 5-FU dosage for phase II evaluations is 1,250 mg/m(2)/wk for 3 weeks every 4 weeks with the intensified PN401 dose schedule (schedule 2). At this dose, systemic exposure to 5-FU as measured by AUC was five-fold higher than that observed after administration of a conventional 5-FU bolus.
