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NCT01390337 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)

A Phase 1 study, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT01390337: Completed Phase 1 study, sponsored by Daiichi Sankyo.

NCT01390337 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01390337, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

The purpose of this study is to define the maximum tolerated dose (MTD) of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.

Interventions

  • DRUG cytarabine
  • DRUG daunorubicin
  • DRUG AC220

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2011-10
Est. Completion 2015-02
Phase Phase 1
Daiichi Sankyo

236 total trials

What the finished NCT01390337 record still lists

NCT01390337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).

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

NCT01390337 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01390337 about?

NCT01390337 is a clinical study titled "A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)". The purpose of this study is to define the maximum tolerated dose (MTD) of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.

What is the current status of trial NCT01390337?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-10. Estimated completion is 2015-02.

What interventions are being tested in trial NCT01390337?

The interventions under investigation include: cytarabine (DRUG), daunorubicin (DRUG), AC220 (DRUG).

Who is sponsoring clinical trial NCT01390337?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01390337's enrollment target sits among peer trials

19 1716th of 2000 higher than 281 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 NCT01390337, the US trial registry maintained by the National Library of Medicine. NCT01390337 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.