Ignite Creation Date:
2024-05-05 @ 9:21 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00866281
Status:
TERMINATED
Last Update Posted:
2015-12-22
First Post:
2009-03-19
Brief Title:
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin PKC412 in Relapsed or Refractory Pediatric Leukemia
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Open-label Dose-escalating Study to Evaluate the Safety Tolerability and Pharmacokinetics of Twice Daily Oral Midostaurin and to Evaluate the Preliminary Clinical and Pharmacodynamic Response in Pediatric Patients With Relapsed or Refractory Leukemia
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Despite considerable efforts to boost recruitment during the final year of the study no new patients were enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase III pediatric dose-ranging study that will evaluate the safety tolerability clinical response pharmacokinetics and pharmacodynamics of midostaurin in patients 18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin including MLL-rearranged ALL and FLT3 positive AML
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2008-006931-11 | EUDRACT_NUMBER | None | None |