Phase I trial of TLC ELL-12 in advanced solid tumors

$0M01FY2000RRNIH

Duke University, Durham NC

Investigators

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Abstract

This study is designed to determine the dose of an investigational anti-cancer drug, TLC ELL-12, for use in phase II studies. TLC ELL-12 is a liposomal formulation of an ether lipid. The study will describe the toxicities and determine the pharmacokinetics and pharmacodynamics of TLC ELL-12. As secondary objectives, the study will describe the antitumor activity of TLC ELL-12 on doses and schedules utilized in this trial. It will also determine the frequency with which TLC ELL-12 induces human platelet aggregation ex vivo. This is a complex study involving two 24-hour in-patient monitoring periods and numerous outpatient visits to obtain samples for pharmacokinetic analysis. During each inpatient period, between 21 and 23 blood samples are drawn, depending on the dose level and infusion rate.

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