Advanced Gastrointestinal Tumors Clinical Trial
Official title:
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Given Daily for 21 Days Followed by 7 Days Off Schedule in Patients With Advanced GI Tumors.
The primary objective of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™ recommended for future phase 2 protocol
This is a Phase 1, open label, multicenter, dose-escalation study of safety,
pharmacokinetics, and pharmacodynamics of Minnelide™
Minnelide™ will be given as a single agent intravenously as a 30-minute infusion daily x 21
days followed by a 7-day rest period. One cycle will equal 28 days. Dose escalation will
follow a modified Fibonacci design.
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