Results of a first-in-man phase I study assessing the safety and pharmacokinetics of a one hour intravenous infusion of DTS-201 every 3 weeks in patients with advanced or metastatic solid tumors

B76 Introduction : DTS-201 is a doxorubicin prodrug which has shown encouraging results in experimental models in terms of both efficacy and safety compared to conventional doxorubicin. The drug is licensed in by Diatos from Medarex Inc with exclusive European rights. A Phase I study has been conducted with a 3 weekly-schedule of the anthracyclin analogue to assess the safety and pharmacokinetics and to determine the maximum tolerated dose (MTD)for consecutive trials. Methods: DTS-201 was administered as a 1 hour iv infusion every 3 weeks in eligible patients. Dose escalation was performed according to a modified Fibonacci schema. PK profiles were obtained in each patient after the first administration. Results: Three centers enrolled 25 pretreated pts; 12 females and 13 males, median age 58 years (range, 30-72), WHO PS