Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533761
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Eganelisib as Monotherapy and in Combination With Cytarabine in RelapsedRefractory AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With RelapsedRefractory Acute Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1b open-label multicenter dose-escalation and dose-optimization study designed to evaluate the safety tolerability pharmacokinetics PK pharmacodynamics PD and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsedrefractory rr acute myeloid leukemia AML or rr higher-risk myelodysplastic syndromes HR-MDS
The study consists of 2 parts
Part 1 Dose Escalation DE in both monotherapy and in combination
Part 2 Dose Optimization
The study consists of 2 parts
Part 1 Dose Escalation DE in both monotherapy and in combination
Part 2 Dose Optimization
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