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NCT01110226 · ClinicalTrials.gov registry record · Phase 1

Trial Of Cisplatin And KML-001 in Platinum Responsive Malignancies

A Phase 1 study, sponsored by University of Maryland, Baltimore.

Terminated
Registry status
Phase 1
Development phase
23
Enrollment target

NCT01110226: Clinical Trial Phase 1 study, sponsored by University of Maryland, Baltimore.

NCT01110226 is a Phase 1 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01110226, a Phase 1 study, was terminated before completion, sponsored by University of Maryland, Baltimore.

TERMINATED
Registry status
Phase 1
Development phase
23 participants
Enrollment target

Study Summary

This is a Phase I Clinical Trial. Phase I studies are designed to determine the amount of investigational drugs that can be safely tolerated and to define the side effects that limit the dose. The drug administered in this study is KML-001. It is a highly soluble, orally available arsenic agent. It is currently being tested to determine its effects on telomerase activity. In other words, the purpose of this research study is to find the highest dose of KML001, that can be given without causing severe side effects when it is combined with a standard, commercially available anti-cancer drug called cisplatin.

Primary Outcome

Once 3 subjects in a cohort reach a dose limiting toxicity. In this protocol, it took 23 months to determine the dose limiting toxicity.

Interventions

  • DRUG Cisplatin
  • DRUG KML-001

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2010-04-27
Est. Completion 2015-10-27
Phase Phase 1
University of Maryland, Baltimore

560 total trials

Why NCT01110226 stopped before completion

NCT01110226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 2 interventions - of which Cisplatin is the first listed.

NCT01110226 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01110226 about?

NCT01110226 is a clinical study titled "Trial Of Cisplatin And KML-001 in Platinum Responsive Malignancies". This is a Phase I Clinical Trial. Phase I studies are designed to determine the amount of investigational drugs that can be safely tolerated and to define the side effects that limit the dose. The drug administered in this study is KML-001. It is a highly soluble, orally available arsenic agent. It ...

What is the current status of trial NCT01110226?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2010-04-27. Estimated completion is 2015-10-27.

What interventions are being tested in trial NCT01110226?

The interventions under investigation include: Cisplatin (DRUG), KML-001 (DRUG).

Who is sponsoring clinical trial NCT01110226?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01110226's enrollment target sits among peer trials

23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01110226, the US trial registry maintained by the National Library of Medicine. NCT01110226 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.