Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04477291
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2020-07-13
Brief Title:
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
Sponsor:
Aptose Biosciences Inc
Organization:
Aptose Biosciences Inc
Study Overview
Official Title:
A Phase 1ab Trial of CG-806 in Patients With RelapsedRefractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes
Status:
ACTIVE_NOT_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 study is being done to evaluate the safety tolerability and antitumor activity of oral CG-806 luxeptinib for the treatment of patients with Acute Myeloid Leukemia except APML secondary AML therapy-related AML or higher-risk MDS whose disease has relapsed is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation
Detailed Description:
This is a multicenter open-label Phase 1 ab dose escalation study of safety pharmacodynamics and pharmacokinetics of CG-806 in ascending cohorts 33 design to determine the MTD or recommended dose in patients with relapsed or refractory Acute Myeloid Leukemia except APML secondary AML therapy-related AML or higher-risk MDS whose disease has relapsed is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation This is to be followed by a cohort expansion phase
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