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Annals of Oncology 13:1925-1934, 2002
© 2002 European Society for Medical Oncology

Original Paper

Clinical phase I and pharmacokinetic study of S 16020, a new olivacine derivative: report on three infusion schedules

A. Awada1,+, S. Giacchetti2, B. Gerard3, P. Eftekhary2, C. Lucas3, D. de Valeriola1, M. G. Poullain3, J. Soudon4, C. Dosquet2, M.-H. Brillanceau5, B. Giroux3, M. Marty2, H. Bleiberg1, F. Calvo2 and M. Piccart1

1 Jules Bordet Institute, Brussels, Belgium; 2 Hôpital St-Louis, Centre d’investigations cliniques, Paris; 3 I.R.I. Servier, Courbevoie; 4 Pharmacell, Paris, France; 5 Servier UK, Fullmer, Slough, UK

Received 27 February 2002; revised 26 April 2002; accepted 13 May 2002

S 16020, a new 9-OH olivacine derivative, is a novel topoisomerase II inhibitor with activity in cell lines presenting the classical multidrug resistance phenotype. This report summarizes, in addition to pharmacokinetic data, the whole phase I clinical experience of S 16020 using three different infusion schedules. Asthenia and skin toxicity were the main side effects. In an attempt to understand the skin toxicity mechanism, experiments in animals were performed, the results of which are reported. S 16020 showed rapid tumor necrotizing activity in some patients, with soft tissue metastases of epidermoïd tumors and pain at the tumor site. To document the side effects of S 16020 and tumor site reactions (pain, edema, inflammatory signs), inflammatory parameters and some cytokines were measured. In our patients there was no hemolysis and no detection of anti-S 16020 antibodies, confirming the absence of immunogenicity of the compound. Based on the overall data of the three infusion schedules of S 16020, the dose of 100 mg/m2 over 3 h every 3 weeks was selected for phase II studies.

Key words: clinical phase I, olivacine derivative, S 16020, solid tumors


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