Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05027867
Status:
TERMINATED
Last Update Posted:
2023-08-16
First Post:
2021-08-25
Brief Title:
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
Sponsor:
Kartos Therapeutics Inc
Organization:
Kartos Therapeutics Inc
Study Overview
Official Title:
An Open-Label Multicenter Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer SCLC
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unanticipated and extremely high screen failure rate There was no evidence of safety concerns in the study
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 for the treatment of patients with relapsed or refractory small cell lung cancer
This study will be conducted in 2 parts Part 1 will evaluate two treatment arms each with a different KRT-232 dose Part 2 will continue the evaluation of the selected treatment arms from Part 1
This study will be conducted in 2 parts Part 1 will evaluate two treatment arms each with a different KRT-232 dose Part 2 will continue the evaluation of the selected treatment arms from Part 1
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