ADVANCED SOLID TUMORS Clinical Trial
Official title:
Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM01183 in Patients With Advanced Solid Tumors
This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors
This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors to identify the dose limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 administered every three weeks intravenously (i.v.) over one hour to patients with advanced solid tumors and to preliminarily determine the pharmacokinetics of PM01183, to evaluate the antitumor activity of PM01183 and the safety and tolerability of PM01183. Besides this study will evaluate the pharmacogenomics in tumor samples and peripheral white blood cells (PWBCs) of patients exposed to PM01183 at the RD in order to assess potential markers of response and/or resistance. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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