NCT03096340

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Intezyne Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Neoplasms
• Tumors
• Refractory Solid Tumors
• Recurrent Solid Tumors

Interventions

Type	Name	Description
DRUG	IT-141	Escalating doses administered in mg/m2, IV (in the vein) on days 1 and 15 of each 28 day cycle until progression or unacceptable toxicity develops.

Timeline

• Start date: 2017-03-23
• Primary completion: 2018-08-22
• Completion: 2019-11-26
• First posted: 2017-03-30
• Last updated: 2020-12-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study