Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001790
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase I Study of the Safety Tolerance and Pharmacokinetics of FK463 in Immunocompromised Children With Fever and Neutropenia
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of the Safety Tolerance and Pharmacokinetics of FK463 in Immunocompromised Children With Fever and Neutropenia
Status:
COMPLETED
Status Verified Date:
1999-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 500mm3 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 05mgkgday not to exceed 25 mgday 10 mgkgday not to exceed 50 mgday 15 mgkgday not to exceed 75 mgday and 20mgkgday not to exceed 100mgday 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 05 mgkgday not to exceed 25 mgday The second group of patients will receive 10 mgkgday not to exceed 50mgday The third group of patients will receive 15 mgkgday not to exceed 75 mgday The fourth group of patients will receive 20mgkgday not to exceed 100mgday Study drug will continue until recovery from neutropenia ANC post nadir greater than or equal 250mm3 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 days For any patient who meets institutional criteria to start standard empirical antifungal therapy with conventional deoxycholate amphotericin B or a lipid formulation of amphotericin B greater than 96 hours on study drug or who has a proven breakthrough fungal infection FK463 will be discontinued and conventional deoxycholate amphotericin B or a lipid formulation of amphotericin B will be initiated
Detailed Description:
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 a one hour infusion to patients with new onset of fever and neutropenia absolute neutrophil count less than or equal to 500mm3 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 05 mgkgday not to exceed 25 mgday 10 mgkgday not to exceed 50 mgday 15 mgkgday not to exceed 75 mgday 20 mgkgday not to exceed 100 mgday 30 mgkgday not to exceed 150 mgday and 40 mgkgday not to exceed 200 mgday The planned sample size is 96 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 120 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 at each dosage level The first group of patients will receive FK463 at 05 mgkgday not to exceed 25 mgday The second group of patients will receive 10 mgkgday not to exceed 50 mgday The third group of patients will receive 15 mgkgday not to exceed 75 mgday The fourth group of patients will receive 20 mgkgday not to exceed 100 mgday The fifth group of patients will receive 30 mgkgday not to exceed 150 mgday The sixth group of patients will receive 40 mgkgday not to exceed 200 mgday Study drug will continue until recovery from neutropenia ANC post nadir greater than or equal 250mm3 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 days For any patient who meets institutional criteria to start standard empirical antifungal therapy with conventional deoxycholate amphotericin B or a lipid formulation of amphotericin B greater than 96 hours on study drug or who has a proven breakthrough fungal infection FK463 will be discontinued and conventional deoxycholate amphotericin B or a lipid formulation of amphotericin B will be initiated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0007 | None | None | None |