Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03125876
Status:
TERMINATED
Last Update Posted:
2021-03-24
First Post:
2017-04-09
Brief Title:
A Phase Ib Study of CT053PTSA in Relapsed Refractory Acute Myeloid Leukemia AML
Sponsor:
Sunshine Lake Pharma Co Ltd
Organization:
Sunshine Lake Pharma Co Ltd
Study Overview
Official Title:
A Phase Ib Multi-center Open Dose-escalation Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of Ningetinib CT053PTSA in Relapsed Refractory Acute Myeloid Leukemia AML
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company strategy adjustment
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 CT053PTSA in Relapsedrefractory AML patients with FLT3 gene mutation
Detailed Description:
It is a multi-center open-label dose escalation study conducted in 2 parts Dose-escalation part Subjects will receive oral CT053PTSA once daily repeatedly until disease progression or unacceptable toxicity occurs each cycle is defined as 28 days At least 3 subjects will receive CT053PTSA at each dose 60 80 100mg for determination of Maximum Tolerated DoseMTD and Dose Limiting Toxicity DLT Dose reduction of CT053PTSA will be considered if study drug-related toxicities are observed in a subject after Cycle 1
Expansion partExpansion cohort might be set to further investigate the safety and efficacy of CT053PTSA at or lower MTD dose recommended by dose-escalation part
Expansion partExpansion cohort might be set to further investigate the safety and efficacy of CT053PTSA 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