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

Cancer Clinical Trial

Official title:
A Phase 1 With Expansion Cohort, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenously Infused IT-141 in Subjects With Recurrent or Refractory Solid Tumors

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03096340
Study type Interventional
Source Intezyne Technologies, Inc.
Contact
Status Terminated
Phase Phase 1
Start date March 23, 2017
Completion date November 26, 2019
View Details
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