Phase I Dose Finding and Pharmacokinetic Study of the Intravenous Camptothecin ST1968 in Patients With Solid Tumors
Multicenter, open label, uncontrolled Phase I pharmacokinetic trial to determine the Maximum
Tolerated Dose (MTD) of ST1968 given intravenously (I.V.) once every week for 2 consecutive
weeks every 3 weeks and the MTD of ST1968 given I.V. once every 3 weeks. A starting dose of
1.5mg/m2 given as a flat dose of 2.5mg is defined, given once on Day 1, Day 8 every 21 Days
(D1, D8 Q21D schedule), over 2 h. Starting dose for the Day 1 every 21 Days (D1 Q21D
schedule) has to be determined from the MTD of D1, D8 Q21D schedule.
Plasma, urine pharmacokinetics in all patients (minimum of 3 pts for each cohort) during the
first cycle of treatment and in at least 6 patients at the Recommended Dose (RD).
During the study any hints of anti-tumor activity will also be evaluated by RECIST criteria.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of ST1968 given I.V. once every week for 2 consecutive weeks every 3 weeks and MTD of ST1968 given I.V. once every 3 weeks
2/6 patients with a Dose Limiting Toxicity (DLT) at the first cycle (21 days)
Dagmar Hess, MD
Kantonsspital St. Gallen, 9700 St. Gallen - Switzerland