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NCT01464593 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Imunon.

Terminated
Registry status
Phase 2
Development phase
2
Enrollment target

NCT01464593: Clinical Trial Phase 2 study, sponsored by Imunon.

NCT01464593 is a Phase 2 study that was terminated before completion, run by Imunon. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01464593, a Phase 2 study, was terminated before completion, sponsored by Imunon.

TERMINATED
Registry status
Phase 2
Development phase
2 participants
Enrollment target

Study 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).

Primary Outcome

Subject's treated with thermal ablation in conjunction with Thermodox to evaluate local tumor control defined as complete ablation and does not experience recurrence within 1 cm of the ablation site.

Interventions

  • DRUG ThermoDox
  • DRUG Lyso-Thermosensitive Liposomal Doxorubicin
  • OTHER 5% Dextrose Solution

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2011-09
Est. Completion 2013-06
Phase Phase 2
Imunon

11 total trials

Why NCT01464593 stopped before completion

NCT01464593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 3 interventions - of which ThermoDox is the first listed.

NCT01464593 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01464593 about?

NCT01464593 is a clinical study titled "Phase 2 Study of Thermodox as Adjuvant Therapy With Thermal Ablation (RFA) in Treatment of Metastatic Colorectal Cancer(mCRC)". 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).

What is the current status of trial NCT01464593?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2011-09. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01464593?

The interventions under investigation include: ThermoDox (DRUG), Lyso-Thermosensitive Liposomal Doxorubicin (DRUG), 5% Dextrose Solution (OTHER).

Who is sponsoring clinical trial NCT01464593?

This trial is sponsored by Imunon, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01464593's enrollment target sits among peer trials

2 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01464593, the US trial registry maintained by the National Library of Medicine. NCT01464593 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.