Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Multicenter, Open-label Study of the Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors
This is an open-label study of palifosfamide-tris administered intravenously on Days 1, 2,
and 3 of a 21-day cycle to subjects with advanced solid tumors. Enrolled subjects will
receive a placebo-control infusion on Day -1 and then commence palifosfamide-tris study
treatment 24 hours later on Day 1.
Time-matched, intensive ECG monitoring will occur during and following placebo and
palifosfamide-tris infusions on Days -1, 1, 2, 3 and 8. Generation of ECG data for study
analysis will be performed in a blinded fashion at a central ECG laboratory.
Blood and urine sampling to characterize the pharmacokinetics of palifosfamide-tris will be
performed on Days 1 through 8 of Cycle 1.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
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