MedTrace Logo

Phase 2 Study of Thermodox as Adjuvant Therapy With Thermal Ablation (RFA) in Treatment of Metastatic Colorectal Cancer(mCRC)

NCT01464593 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-10-13

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine the safety and efficacy of Thermodox, a thermally sensitive liposomal doxorubicin, in combination with thermal ablation in the treatment of hepatic colorectal liver metastases (CRLM).

Conditions

  • Colon Cancer Liver Metastasis

Interventions

DRUG

Lyso-Thermosensitive Liposomal Doxorubicin

Thermally sensitive liposomal doxorubicin 50 mg/m2 single 30 minute intravenous infusion.

OTHER

5% Dextrose Solution

Single 30 minute intravenous infusion

DRUG

ThermoDox

ThermoDox is a Lyso-thermosensitive Liposomal Doxorubicin designed to be used in conjunction with thermal ablation.

Sponsors & Collaborators

  • Imunon

    lead INDUSTRY

Principal Investigators

  • Nicholas Borys, M.D. · Imunon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01464593 on ClinicalTrials.gov