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

NCT03096340 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-12-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Intezyne Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Minal Barve, MD · Mary Crowley Cancer Research Centers - Medical City

  • Kit Wong, MD · Seattle Cancer Care Alliance

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2018-08-22
Completion
2019-11-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03096340 on ClinicalTrials.gov