Ignite Creation Date:
2024-05-06 @ 1:46 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04113616
Status:
TERMINATED
Last Update Posted:
2024-03-22
First Post:
2019-10-01
Brief Title:
An Open-Label Multicenter Phase 1b2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine LDAC or Decitabine in Patients With Acute Myeloid Leukemia AML
Sponsor:
Kartos Therapeutics Inc
Organization:
Kartos Therapeutics Inc
Study Overview
Official Title:
An Open-Label Multicenter Phase 1b2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine LDAC or Decitabine in Patients With Acute Myeloid Leukemia AML
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
In September 2023 the study was terminated because of a Sponsor decision unrelated to safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates KRT-232 a novel oral small molecule inhibitor of MDM2 when administered alone and in combination with low-dose cytarabine LDAC or Decitabine for the treatment of adults with Acute Myeloid Leukemia AML and AML secondary to myeloproliferative neoplasms MPN Participants must be relapsedrefractory having failed prior therapy and will be assigned to receive monotherapy KRT-232 alone or combination therapy KRT-232 with LDAC or KRT-232 with Decitabine
Detailed Description:
None
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