Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03662126
Status:
RECRUITING
Last Update Posted:
2023-04-28
First Post:
2018-09-05
Brief Title:
KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
Sponsor:
Kartos Therapeutics Inc
Organization:
Kartos Therapeutics Inc
Study Overview
Official Title:
A Phase 23 Randomized Controlled Open-Label Study of KRT 232 in Subjects With Primary Myelofibrosis PMF Post Polycythemia Vera MF Post-PV-MF Or Post Essential Thrombocythemia MF Post-ET-MF Who Are Relapsed or Refractory to Janus Kinase JAK Inhibitor Treatment
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOREAS
Brief Summary:
This study evaluates KRT-232 a novel oral small molecule inhibitor of MDM2 for the treatment of patients with myelofibrosis MF who no longer benefit from treatment with a JAK inhibitor Inhibition of MDM2 is a novel mechanism of action in MF
This study will be conducted in 2 phases Phase 2 will determine the KRT-232 recommended dose and dosing schedule Phase 3 will test KRT-232 vs Best Available Therapy BAT Patients in the Phase 3 part of the study will be randomized 21 to receive either KRT-232 Arm 1 or BAT Arm 2 The BAT administered will be determined by the treating physician with the option to cross-over to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time
This study will be conducted in 2 phases Phase 2 will determine the KRT-232 recommended dose and dosing schedule Phase 3 will test KRT-232 vs Best Available Therapy BAT Patients in the Phase 3 part of the study will be randomized 21 to receive either KRT-232 Arm 1 or BAT Arm 2 The BAT administered will be determined by the treating physician with the option to cross-over to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time
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?:
True
Is an FDA AA801 Violation?:
None