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NCT00001790 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children With Fever and Neutropenia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT00001790: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001790 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001790, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety, tolerance, and pharmacokinetics of FK463, a novel echinocandin (cell wall-active antifungal lipopeptide), as early empirical therapy for prevention of fungal infections in immunocompromised children. The study is designed as a multicenter open label, sequential dose escalation study of intravenous FK463. Intravenous FK463 will be administered daily as an hour infusion to patients with new onset of fever and neutropenia (absolute neutrophil count less than or equal to 500/mm3) who will be initiated onto broad spectrum empirical antibacterial therapy. The patient population consists of children ages 2 to 17 years of age; two age cohorts will be studied (2-12, 13-17). Dosage levels will be 0.5mg/kg/day (not to exceed 25 mg/day), 1.0 mg/kg/day (not to exceed 50 mg/day), 1.5 mg/kg/day (not to exceed 75 mg/day) and 2.0mg/kg/day (not to exceed 100mg/day). The planned sample size is 64 patients (a maximum of two replacement patients may be added to a given dose level and age cohort, for a total of no more than 10 patients per dose level and age cohort. The study will enroll no more than 80 patients). At each dosage level, a total of 8 patients will be enrolled into each age cohort (2-12, 13-17); a total of 16 patients will be enrolled into each dosage level. The first group of patients will receive FK463 at 0.5 mg/kg/day (not to exceed 25 mg/day). The second group of patients will receive 1.0 mg/kg/day (not to exceed 50mg/day). The third group of patients will receive 1.5 mg/kg/day (not to exceed 75 mg/day). The fourth group of patients will receive 2.0mg/kg/day (not to exceed 100mg/day). Study drug will continue until recovery from neutropenia (ANC post nadir greater than or equal 250/mm3) or until the initiation of conventional deoxycholate amphotericin B or a lipid formulation of amphotericin B for empirical antifungal therapy or for proven fungal infection. Patients may receive FK463 for a maximum duration of 14 day
Interventions
- DRUG FK463
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 1998-10 |
| Est. Completion | 2000-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001790
The ClinicalTrials.gov registry entry for NCT00001790 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which FK463 is the first listed.
NCT00001790 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001790 about?
NCT00001790 is a clinical study titled "Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children With Fever and Neutropenia". The objective of this study is to evaluate the safety, tolerance, and pharmacokinetics of FK463, a novel echinocandin (cell wall-active antifungal lipopeptide), as early empirical therapy for prevention of fungal infections in immunocompromised children. The study is designed as a multicenter open l...
What is the current status of trial NCT00001790?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 1998-10. Estimated completion is 2000-09.
What interventions are being tested in trial NCT00001790?
The interventions under investigation include: FK463 (DRUG).
Who is sponsoring clinical trial NCT00001790?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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