Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors
This trial intends to determine the maximum tolerated dose and the recommended dose, to
evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the
antitumor activity of PM060184 in patients with advanced solid tumors.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.
To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM060184 administered on Days 1 and 8 of a 21-day cycle intravenously (i.v.) over 10 minutes to patients with advanced solid tumors.
From treatment onset to end of treatment
Kyriakos Papadopoulos, MD
START- South Texas Accelerated Research Therapeutics, LLC
United States: Food and Drug Administration
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