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Annals of Oncology 13:385-391, 2002
© 2002 European Society for Medical Oncology

Phase I study of MEN-10755, a new anthracycline in patients with solid tumours: a report from the European Organization for Research and Treatment of Cancer, Early Clinical Studies Group

D. Schrijvers, A. M. E. Bos1, J. Dyck, E. G. E. de Vries1, J. Wanders2, M. Roelvink2, P. Fumoleau3, S. Bortini4 and J. B. Vermorken+

Department of Medical Oncology, University Hospital Antwerp, Edegem, Belgium; 1Department of Medical Oncology, University Hospital Groningen, Groningen; 2NDDO Oncology, Free University Hospital, Amsterdam, The Netherlands; 3European Organization for Research and Treatment of Cancer, Early Clinical Studies Group, Brussels, Belgium; 4Menarini Ricerche S.p.A, Italy

Received 19 June 2001; revised 20 August 2001; accepted 5 September 2001.

A phase I study was performed with MEN-10755, a novel anthracycline with promising preclinical antitumour activity, in patients with solid tumours to determine the maximum tolerated dose (MTD); the dose-limiting toxicities (DLTs); to document antitumour activity; and to propose a safe dose for phase II evaluation. MEN-10755 at a starting dose of 15 mg/m2/week was given by short intravenous infusion weekly for 3 weeks and cycles were repeated every 28 days.

Twenty-four patients received 55 cycles. Doses of MEN-10755 were 15, 30, 40 and 45 mg/m2.

At a dose of MEN-10755 45 mg/m2, treatment could not be given as planned due to neutropenia and one patient developed a decrease in cardiac function. This dose level was considered to be the MTD. Chemotherapy-naive patients could be treated with 40 mg/m2/week, and only one DLT (grade 4 neutropenia) was observed. At that dose, three of six chemotherapy pretreated patients developed a DLT during their first treatment cycle: one patient developed a grade 4 thrombocytopenia, one patient a grade 4 neutropenia and one patient developed a grade 3 acute hypersensitivity reaction resulting in discontinuation of treatment. At this dose level, one other patient did not receive treatment on day 15 as planned due to grade 3 neutropenia. No responses were observed.

MEN-107555 at a dose of 30 mg/m2/week in pretreated patients and 40 mg/m2/week in chemotherapy-naive patients for three consecutive weeks followed by 1 week rest is recommended for phase II testing.

Key words: anthracyclines, dose-limiting toxicity, maximum tolerated dose, MEN-10755, pharmokinetics, phase I


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