Ignite Creation Date:
2024-05-06 @ 1:25 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04015024
Status:
UNKNOWN
Last Update Posted:
2019-07-16
First Post:
2019-05-22
Brief Title:
A Clinical Study of SKLB1028 Capsule in the Treatment of RecurrenceRefractory AML Patients
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co Ltd
Organization:
CSPC ZhongQi Pharmaceutical Technology Co Ltd
Study Overview
Official Title:
Phase IIa Clinical Study of SKLB1028 Capsule in the Treatment of FLT3 Mutation Recurrence Refractory AML Patients
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
NOT_YET_RECRUITING
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:
Patients will receive oral SKLB1028 for 28 days as a course of treatment and then to evaluate the side effectstolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations
Detailed Description:
It is an openmulticenterqueue extension study designed to characterize the efficacy and safety of different administration regimens of SKLB1028 capsules in patients with recurrentrefractory acute myeloid leukemia with FLT3 mutation Divided into three dose groups150mg BID200mg BID300mg QD The main end point is total remission rate ORR total survival time OS progress-free survival time PFS remission duration FLT3 suppression rate competitive parameters safety incidence of adverse events
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