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NCT02238925 · ClinicalTrials.gov registry record · Phase 2

An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients

A Phase 2 study, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
26
Enrollment target

NCT02238925: Completed Phase 2 study, sponsored by Jazz Pharmaceuticals.

NCT02238925 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02238925, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
26 participants
Enrollment target

Study Summary

The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization, assess plasma drug levels, asses serum copper levels, and assess drug levels in urine. Efficacy and Safety will be assessed in all patients enrolled to the study.

Primary Outcome

Time-matched QTcF Changes From Baseline after the start of first infusion

Interventions

  • DRUG CPX-351

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2014-07
Est. Completion 2016-01
Phase Phase 2
Jazz Pharmaceuticals

128 total trials

What the finished NCT02238925 record still lists

NCT02238925 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which CPX-351 is the first listed.

NCT02238925 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02238925 about?

NCT02238925 is a clinical study titled "An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients". The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization, assess plasma drug levels, asses serum copper levels, and assess drug levels in urine. Efficacy and Safety will be assessed in all patients enrolled to the study.

What is the current status of trial NCT02238925?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2014-07. Estimated completion is 2016-01.

What interventions are being tested in trial NCT02238925?

The interventions under investigation include: CPX-351 (DRUG).

Who is sponsoring clinical trial NCT02238925?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02238925's enrollment target sits among peer trials

26 1708th of 2000 higher than 282 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 NCT02238925, the US trial registry maintained by the National Library of Medicine. NCT02238925 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.