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NCT00788892 · ClinicalTrials.gov registry record · Phase 2

Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

A Phase 2 study, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
126
Enrollment target

NCT00788892: Completed Phase 2 study, sponsored by Jazz Pharmaceuticals.

NCT00788892 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00788892, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
126 participants
Enrollment target

Study Summary

The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens. The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.

Primary Outcome

Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of \>1000/µL and peripheral blood platelets of \>100,000/µL in the absence of bone marrow blasts.

Interventions

  • DRUG Cytarabine
  • DRUG Daunorubicin
  • DRUG CPX-351

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 2008-10
Est. Completion 2011-12
Phase Phase 2
Jazz Pharmaceuticals

128 total trials

What the finished NCT00788892 record still lists

NCT00788892 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

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

NCT00788892 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00788892 about?

NCT00788892 is a clinical study titled "Trial of CPX-351 in Newly Diagnosed Elderly AML Patients". The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens. The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.

What is the current status of trial NCT00788892?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2008-10. Estimated completion is 2011-12.

What interventions are being tested in trial NCT00788892?

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

Who is sponsoring clinical trial NCT00788892?

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 NCT00788892's enrollment target sits among peer trials

126 556th of 2000 higher than 1,443 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 NCT00788892, the US trial registry maintained by the National Library of Medicine. NCT00788892 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.