Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia
- Determine the safety, tolerability, and pharmacokinetics of anidulafungin in
immunocompromised children with neutropenia.
- Determine the frequency of deeply invasive fungal infections in children receiving this
drug for early empirical therapy.
OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to
1 of 2 groups according to age (2 to 11 years vs 12 to 17 years).
Patients receive anidulafungin IV once daily over 45-120 minutes. In both groups, cohorts of
6 patients receive escalating doses of anidulafungin. Treatment continues for up to 28 days
or until patients recover from neutropenia or become eligible for standard empirical
antifungal therapy in the absence of unacceptable toxicity or breakthrough fungal infection.
Patients are followed at 7-9 days.
PROJECTED ACCRUAL: A total of 25 patients (approximately 12 per group) were accrued for this
Masking: Open Label, Primary Purpose: Supportive Care
Thomas J. Walsh, MD
National Cancer Institute (NCI)
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Lombardi Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|