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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00430443
The ClinicalTrials.gov registry entry for NCT00430443 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Callisto Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Liposomal Annamycin is the first listed.
NCT00430443 reports 0 study locations.
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.
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