Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04910152
Status:
TERMINATED
Last Update Posted:
2024-04-25
First Post:
2021-04-24
Brief Title:
Novel BET Inhibitor PLX51107 for Steroid-Refractory Acute GVHD
Sponsor:
Hannah Choe MD
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Single Arm Open Label Phase 1b2 Study of Novel BET Inhibitor PLX51107 for Steroid-Refractory Acute GVHD
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IbII trial studies the side effects of PLX51107 in treating steroid-refractory acute graft versus host disease GVHD PLX51107 is a novel potent non-benzodiazepine structured small molecule BET inhibitor with a unique binding mode selective for BRD4 inhibition and a more tolerable side effect profile PLX51107 may work better in treating steroid-refractory acute GVHD
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and tolerability of BRD4 inhibitor PLX51107 PLX51107 as a single agent for allogeneic transplant recipients with steroid-refractory acute graft versus host disease GVHD
II To assess the pharmacokinetic PK and pharmacodynamic PD of orally administered PLX51107 in steroid-refractory acute GVHD patients
SECONDARY OBJECTIVE
I To evaluate the preliminary efficacy of PLX51107 in steroid-refractory acute GVHD patients
OUTLINE
Patients receive BRD4 inhibitor PLX51107 orally PO once daily QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then up to 6 months
I To evaluate the safety and tolerability of BRD4 inhibitor PLX51107 PLX51107 as a single agent for allogeneic transplant recipients with steroid-refractory acute graft versus host disease GVHD
II To assess the pharmacokinetic PK and pharmacodynamic PD of orally administered PLX51107 in steroid-refractory acute GVHD patients
SECONDARY OBJECTIVE
I To evaluate the preliminary efficacy of PLX51107 in steroid-refractory acute GVHD patients
OUTLINE
Patients receive BRD4 inhibitor PLX51107 orally PO once daily QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then up to 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-02282 | REGISTRY | None | None |
| R01CA252469 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchR01CA252469 |