Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00430443 · ClinicalTrials.gov registry record · Phase 1
Liposomal Annamycin in Children and Young Adults With Refractory or Relapsed ALL or AML
A Phase 1 study, sponsored by Callisto Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00430443: Clinical Trial Phase 1 study, sponsored by Callisto Pharmaceuticals.
NCT00430443 is a Phase 1 study that was terminated before completion, run by Callisto Pharmaceuticals. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00430443, a Phase 1 study, was terminated before completion, sponsored by Callisto Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Six dose levels of liposomal annamycin are planned: 130, 160, 190, 230, 280, and 310 mg/m2/day.The primary objectives of this study are 1) to evaluate the safety and identify the maximum tolerated dose (MTD) of liposomal annamycin when given in 3 consecutive daily doses, starting at 130 mg/m2/day and ranging to as high as 310 mg/m2/day, or the MTD, whichever is lower, in children and young adults with refractory or relapsed acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML), and 2) to evaluate the antileukemic activity of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. The secondary objective is to measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
Interventions
- DRUG Liposomal Annamycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-02 |
| Est. Completion | 2009-01 |
| Phase | Phase 1 |
Why NCT00430443 stopped before completion
NCT00430443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Liposomal Annamycin is the first listed.
NCT00430443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00430443 about?
NCT00430443 is a clinical study titled "Liposomal Annamycin in Children and Young Adults With Refractory or Relapsed ALL or AML". This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the MTD. The liposomal annamycin do...
What is the current status of trial NCT00430443?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2007-02. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00430443?
The interventions under investigation include: Liposomal Annamycin (DRUG).
Who is sponsoring clinical trial NCT00430443?
This trial is sponsored by Callisto Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00430443's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia