Ignite Creation Date:
2024-05-06 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03671564
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2018-09-04
Brief Title:
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia AML
Sponsor:
Daiichi Sankyo Co Ltd
Organization:
Daiichi Sankyo
Study Overview
Official Title:
Phase 1 Open-label Dose Escalation Study of Milademetan an Oral MDM2 Inhibitor to Assess Safety Tolerability and Pharmacokinetics in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2023-01
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:
None
Brief Summary:
This is a Phase 1 multicenter open-label study to evaluate safety tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia The milademetan initial dose will be Level 1 90 mg No increase in the milademetan dose will be made in the same participant Dose-limiting toxicity associated with milademetan occurring at each level will be assessed and the maximum tolerated dose MTD will be decided using a modified continuous reassessment method mCRM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 184054 | REGISTRY | JAPIC CTI | None |