Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04827069
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2021-03-22
Brief Title:
A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid LeukemiaAML
Sponsor:
Sunshine Lake Pharma Co Ltd
Organization:
Sunshine Lake Pharma Co Ltd
Study Overview
Official Title:
A Phase I Multi-center OpenSingle Arm Dose-escalation Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of Clifutinib BesylateHEC73543 in Relapsed or Refractory Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2024-09
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:
The purpose of this study is to evaluate the safety tolerability pharmacokinetics PK and pharmacodynamics PD of Clifutinib Besylate in Relapsedrefractory AML patients with FLT3-ITD mutation
Detailed Description:
It is a multi-center open-label single arm study conducted in 2 parts Dose-escalation part Subjects will receive oral Clifutinib Besylate once on C0D1After 3 daysthey will receive Clifutinib Besylate once daily repeatedly until disease progression or unacceptable toxicity occurs each cycle is defined as 28 days
Expansion partExpansion cohort might be set to further investigate the safety and efficacy of Clifutinib Besylate at or lower MTD dose recommended by dose-escalation part
Expansion partExpansion cohort might be set to further investigate the safety and efficacy of Clifutinib Besylate at or lower MTD dose recommended by dose-escalation part
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?:
None
Is an FDA AA801 Violation?:
None