Phase I and pharmacokinetic study of brequinar (DUP 785; NSC 368390) in cancer patients

Eur J Cancer. 1993;29A(7):983-8. doi: 10.1016/s0959-8049(05)80206-0.

Abstract

Brequinar (DUP 785, NSC 368390) is a 4-quinoline carboxylic acid derivative with broad spectrum antitumour activity in experimental models that acts as an antimetabolite by specific inhibition of de novo pyrimidine synthesis. We performed a phase I study of brequinar administered as a 10 min intravenous (i.v.) infusion for 5 consecutive days, every 4 weeks. 67 evaluable patients were entered in this study and a total of 130 courses were administered at doses ranging from 2 to 350 mg/m2. The dose-limiting toxicity was myelosuppression with predominant thrombocytopenia. Myelosuppression was dose-related and non-cumulative, with considerable interpatient variability depending on haematological risk factors. The maximum tolerated dose of brequinar was 210 mg/m2/day in poor risk patients whereas patients with good risk haematological profile tolerated higher doses (up to 350 mg/m2/day). Other non-limiting toxicities included nausea and vomiting, mucositis and skin reactions. Brequinar plasma pharmacokinetic profiles were biphasic with alpha half-life ranging from 0.1 to 0.7 h, and beta half-life ranging from 1.5 to 8.2 h. Increase in brequinar area under the plasma concentration versus time curves (AUC) was nonlinear. Day 5 brequinar pharmacokinetics obtained in 21 patients indicated a significant increase in AUC (47%) and half-life beta (133%) compared to day 1 pharmacokinetics in the same patient. Brequinar plasma AUC and the per cent change in platelet count at nadir were correlated (P < 0.001). Although no objective response was observed in this study, one minor response was noted in cervical lymph nodes of a Hodgkin's disease patient.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / pharmacokinetics
  • Antineoplastic Agents / therapeutic use*
  • Biphenyl Compounds / adverse effects
  • Biphenyl Compounds / pharmacokinetics
  • Biphenyl Compounds / therapeutic use*
  • Dose-Response Relationship, Drug
  • Female
  • Genital Neoplasms, Female / blood
  • Genital Neoplasms, Female / drug therapy
  • Half-Life
  • Head and Neck Neoplasms / blood
  • Head and Neck Neoplasms / drug therapy
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Thrombocytopenia / chemically induced

Substances

  • Antineoplastic Agents
  • Biphenyl Compounds
  • brequinar