Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04155580
Status:
TERMINATED
Last Update Posted:
2023-02-21
First Post:
2019-11-05
Brief Title:
A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With RelapsedRefractory Acute Myeloid Leukemia AML
Sponsor:
Astex Pharmaceuticals Inc
Organization:
Astex Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Parallel Open-Label Study of the Safety and Tolerability Pharmacokinetics and Antileukemic Activity of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With RelapsedRefractory RR Acute Myeloid Leukemia AML
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted prematurely and will not resume participants are no longer being examined or receiving intervention
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety pharmacokinetics PK and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsedrefractory RR acute myeloid leukemia AML The duration of the study is expected to be approximately 30 months
Detailed Description:
This is a three-part dose escalation and dose expansion Phase 1 study of ASTX660 alone and in combination with ASTX727 in adults with RR AML
Part 1 is an open-label single arm dose escalation with ASTX660 in combination with ASTX727 at the standard fixed dose combination FDC
Part 2 is an open-label randomized dose escalation intended to evaluate ASTX660 as a monotherapy and ASTX660 in combination with ASTX727 FDC
Part 3 is an exploratory single arm dose expansion to further expand the number of participants treated with ASTX660 in combination with ASTX727 FDC
Part 1 is an open-label single arm dose escalation with ASTX660 in combination with ASTX727 at the standard fixed dose combination FDC
Part 2 is an open-label randomized dose escalation intended to evaluate ASTX660 as a monotherapy and ASTX660 in combination with ASTX727 FDC
Part 3 is an exploratory single arm dose expansion to further expand the number of participants treated with ASTX660 in combination with ASTX727 FDC
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