Overview

Safety and Pharmacokinetic Study of IT-141 in Monotherapy in Patients With Advanced Cancer

Status:
Terminated
Trial end date:
2019-11-26
Target enrollment:
Participant gender:
Summary
IT141 is a novel nanoparticle formulation of SN-38, the active metabolite of irinotecan, and is intended to deliver more drug to the tumor with reduced toxicity on normal tissues. The study is designed to determine the maximum tolerated dose (MTD) of IT-141, and to investigate pharmacokinetic (PK) parameters and possible pharmacodynamics (PD) relationships. Patients will also be monitored for any response to therapy.
Phase:
Phase 1
Details
Lead Sponsor:
Intezyne Technologies, Inc.
Treatments:
10-hydroxycamptothecin
Irinotecan