Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460421
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2007-04-12
Brief Title:
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics PK of Palifermin in Subjects With Acute Leukemias Undergoing HSCT
Sponsor:
Swedish Orphan Biovitrum
Organization:
Swedish Orphan Biovitrum
Study Overview
Official Title:
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics PK of Palifermin in Pediatric Subjects With Acute Leukemias Undergoing Myeloablative Therapy and Allogeneic Hematopoietic Stem Cell Transplant HSCT
Status:
COMPLETED
Status Verified Date:
2014-11
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:
20010133 is an open-label dose escalation study in pediatric patients with acute leukemias receiving myelotoxic therapy high dose etoposide cyclophosphamide and total body irradiation TBI followed by hematopoietic stem cell transplant HSCT The study will evaluate the safety and pharmacokinetics of palifermin in pediatric patients Three doses 40 μgkgday 60 μgkgday and 80 μgkgday are to be evaluated in each age group 1 to 2 3 to 11 and 12 to 16 years respectively using a conventional dose escalation design Palifermin is administered for 3 consecutive days Day -10 to Day -8 respectively before the start of the conditioning regimen and for 3 consecutive days Day 0 to Day 2 following HSCT Patients will be enrolled simultaneously to each age group to identify a safe well tolerated efficacious dose in each age group Patients will also be followed for secondary malignancies progression-free survival PFS and overall survival OS
Detailed Description:
None
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