Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064311
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2003-07-08
Brief Title:
Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell Transplantation
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I-II Safety Tolerability And Pharmacokinetic Study Of Ravuconazole For Prophylaxis Of Invasive Fungal Infections In Patients Undergoing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2012-03
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:
RATIONALE Antifungals such as ravuconazole may be effective in preventing fungal infections in patients undergoing chemotherapy and stem cell transplantation
PURPOSE Phase III trial to study the effectiveness of ravuconazole in preventing fungal infections in patients undergoing allogeneic stem cell transplantation
PURPOSE Phase III trial to study the effectiveness of ravuconazole in preventing fungal infections in patients undergoing allogeneic stem cell transplantation
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of ravuconazole for the prevention of invasive fungal infections in patients undergoing non-myeloablative allogeneic hematopoietic stem cell transplantation
Determine the pharmacokinetics and efficacy of this drug in terms of frequency of breakthrough fungal infections and requirement for empirical antifungal therapy in these patients
Determine the effect of this drug on concurrently administered cyclosporine in these patients
Determine the pharmacokinetics of this drug with and without cyclosporine in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive oral ravuconazole once daily beginning within 48 hours of the chemotherapy preparative regimen and before the initiation of cyclosporine Treatment continues until blood counts recover in the absence of unacceptable toxicity
Cohorts of 8 patients receive escalating doses of ravuconazole until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose-limiting toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Determine the safety and tolerability of ravuconazole for the prevention of invasive fungal infections in patients undergoing non-myeloablative allogeneic hematopoietic stem cell transplantation
Determine the pharmacokinetics and efficacy of this drug in terms of frequency of breakthrough fungal infections and requirement for empirical antifungal therapy in these patients
Determine the effect of this drug on concurrently administered cyclosporine in these patients
Determine the pharmacokinetics of this drug with and without cyclosporine in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive oral ravuconazole once daily beginning within 48 hours of the chemotherapy preparative regimen and before the initiation of cyclosporine Treatment continues until blood counts recover in the absence of unacceptable toxicity
Cohorts of 8 patients receive escalating doses of ravuconazole until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose-limiting toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-0205 | None | None | None |
| CDR0000315356 | None | None | None |