Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05424380
Status:
TERMINATED
Last Update Posted:
2024-01-26
First Post:
2022-06-15
Brief Title:
A Phase 1 Open Label Study of Intravenous GSK3745417 to Evaluate Safety Tolerability Pharmacokinetics Pharmacodynamics and Determine RP2D Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase 1 Open Label Study of Intravenous GSK3745417 to Evaluate Safety Tolerability Pharmacokinetics Pharmacodynamics and Determine RP2D and Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including Acute Myeloid Leukemia AML and High-risk Myelodysplastic Syndrome HR-MDS
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The protocol was terminated on the basis of a reprioritization of organizational allocation of resources for clinical research programs
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 1 open label two-part study to determine recommended phase 2 dose RP2D and schedule of GSK3745417 administration in participants with relapsedrefractory AML or HR-MDS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None