Solid Tumors Clinical Trial
Official title:
Phase I Dose Finding and Pharmacokinetic Study of the Intravenous Camptothecin ST1968 in Patients With Solid Tumors
ST1968 is a novel camptothecin derivative which interacts with topoisomerase I-DNA complex, inducing S-Phase specific cytotoxicity. It is endowed with a potent antitumor activity and an increased Therapeutic Index with respect to the clinically used analogues (i.e.irinotecan and topotecan) in some xenograft models (ovary, colon, head & neck, cervix). Anti-tumor activity has been also noted in platinum resistant ovarian cell xenografts and in topoisomerase I mutant prostate cell lines. The acceptable toxicity profile in animals and the activity in camptothecin-resistant cell lines make ST1968 a good candidate for clinical trials.
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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