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NCT03113071 · ClinicalTrials.gov registry record · Phase 1

Safety and Activity of Digoxin With Decitabine in Adult AML and MDS

A Phase 1 study, sponsored by Fox Chase Cancer Center.

Terminated
Registry status
Phase 1
Development phase
1
Enrollment target

NCT03113071: Clinical Trial Phase 1 study, sponsored by Fox Chase Cancer Center.

NCT03113071 is a Phase 1 study that was terminated before completion, run by Fox Chase Cancer Center. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03113071, a Phase 1 study, was terminated before completion, sponsored by Fox Chase Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

The primary hypothesis is that digoxin can be safely added to decitabine and will increase the response rates in medically unfit patients with newly diagnosed AML/MDS or those with relapsed/refractory AML/MDS. Furthermore, it is hypothesized that the addition of digoxin to decitabine will result in distinct epigenetic alterations in AML/MDS patients.

Primary Outcome

Maximum tolerated dose of digoxin in combination with standard dose of decitabine will be determined by a standard 3+3 dose de-escalation design

Interventions

  • DRUG Decitabine
  • DRUG Digoxin

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2017-06-02
Est. Completion 2019-03-11
Phase Phase 1
Fox Chase Cancer Center

183 total trials

Why NCT03113071 stopped before completion

NCT03113071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).

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

NCT03113071 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03113071 about?

NCT03113071 is a clinical study titled "Safety and Activity of Digoxin With Decitabine in Adult AML and MDS". The primary hypothesis is that digoxin can be safely added to decitabine and will increase the response rates in medically unfit patients with newly diagnosed AML/MDS or those with relapsed/refractory AML/MDS. Furthermore, it is hypothesized that the addition of digoxin to decitabine will result in ...

What is the current status of trial NCT03113071?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2017-06-02. Estimated completion is 2019-03-11.

What interventions are being tested in trial NCT03113071?

The interventions under investigation include: Decitabine (DRUG), Digoxin (DRUG).

Who is sponsoring clinical trial NCT03113071?

This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03113071's enrollment target sits among peer trials

1 2001st of 2000 the lowest 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 NCT03113071, the US trial registry maintained by the National Library of Medicine. NCT03113071 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.