A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579 AM3)

Status: Recruiting
Phase:
Diagnosis: Pediatric Hematopoetic Stem Cell Transplant (HSCT), Pediatric Oncology
NCT ID: NCT01716234 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-303

 

The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Christine Duncan, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Documented or anticipated neutropenia expected to last at least 7 days and only in the following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia; autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT during the pre-engraftment (neutropenia) period - Participants of child-bearing potential must use a medically accepted method of contraception throughout the study and for at least 30 days after stopping study medication, unless they are surgically or medically sterile or agree to remain abstinent. Exclusion Criteria: - Proven invasive fungal infection (IFI) before study entry - Severe nausea and/or vomiting at screening - Received posaconazole within 10 days before screening - Laboratory tests outside normal limits for aspartate transaminase (AST) or alanine transaminase (ALT), serum total bilirubin, or calculated creatinine clearance - Prolongation of the corrected QT (QTc) interval on electrocardiogram - Unable to receive study drug by mouth or via an intestinal (enteral) tube - Females who are pregnant, intend to become pregnant during the study, or are breastfeeding
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