Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03760523
Status:
TERMINATED
Last Update Posted:
2024-02-22
First Post:
2018-11-27
Brief Title:
Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase 11b Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Toxicity -Two DLT events occurred
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to determine the safety and recommended dosing of Minnelide in Acute Myeloid Leukemia AML
Detailed Description:
This phase 1 dose escalation clinical trial will establish the maximum tolerated dose MTD and recommended phase 2 dose RP2D of Minnelide as single-agent in relapsedrefractory RR acute myeloid leukemia AML patients who are ineligible to receive intensive chemotherapy The oral formulation of Minnelide will be used Minnelide is a prodrug of triptolide a potent heat shock protein HSP 70 inhibitor with promising preclinical activity in AML
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