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NCT00389428 · ClinicalTrials.gov registry record · Phase 1
Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
A Phase 1 study of Hematologic Neoplasms, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 4
- Study locations
NCT00389428: Completed Phase 1 study of Hematologic Neoplasms, sponsored by Jazz Pharmaceuticals.
NCT00389428 is a Phase 1 study of Hematologic Neoplasms that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 48 participants, below the 1,024-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00389428, a Phase 1 study of Hematologic Neoplasms, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 4
- Study locations
Study Summary
The primary objective of this study is to determine the recommended dose of CPX-351 for use in a phase 2 efficacy study in patients with leukemia. Secondarily, the study will assess the safety, serious adverse effects and how the body handles CPX-351. Preliminary evidence of antitumor activity will also be determined.
Conditions Studied
Interventions
- DRUG CPX-351 (Cytarabine:Daunorubicin) Liposome Injection
Study Locations (4)
New York
- North Shore University Hospital - Manhasset
- New York Presbyterian Hospital Weill Medical College of Cornell University - New York
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Florida
- H. Lee Moffit Cancer Center & Research Institute at the University of S. Florida - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
What the finished NCT00389428 record still lists
NCT00389428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,024-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Hematologic Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which CPX-351 (Cytarabine:Daunorubicin) Liposome Injection is the first listed.
NCT00389428 reports a single indexed study location in New York, District of Columbia, Florida.
Frequently Asked Questions
What is clinical trial NCT00389428 about?
NCT00389428 is a clinical study titled "Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.". The primary objective of this study is to determine the recommended dose of CPX-351 for use in a phase 2 efficacy study in patients with leukemia. Secondarily, the study will assess the safety, serious adverse effects and how the body handles CPX-351. Preliminary evidence of antitumor activity will ...
What is the current status of trial NCT00389428?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2006-09. Estimated completion is 2009-12.
What conditions does trial NCT00389428 study?
This clinical trial studies the following conditions: Hematologic Neoplasms.
What interventions are being tested in trial NCT00389428?
The interventions under investigation include: CPX-351 (Cytarabine:Daunorubicin) Liposome Injection (DRUG).
Who is sponsoring clinical trial NCT00389428?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00389428 being conducted?
This trial has 4 study locations across District of Columbia, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00389428's enrollment target sits among peer trials
48 15th of 20 higher than 6 of 20 other Hematologic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Neoplasms 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.
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