Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02859948
Status:
UNKNOWN
Last Update Posted:
2016-08-09
First Post:
2016-06-28
Brief Title:
A Study of SKLB1028 in Subjects With RelapsedRefractory Acute Myeloid Leukemia
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co Ltd
Organization:
CSPC ZhongQi Pharmaceutical Technology Co Ltd
Study Overview
Official Title:
Phase I Open-Label Sequential Dose Escalation Study Investigating the Safety Tolerability Pharmacokinetics and Pharmacodynamics of SKLB1028 When Administered Daily to Patients With Relapsed or Refractory Acute Myeloid Leukemia
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
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 to study the side effects tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations
Detailed Description:
It is open-label dose escalation study designed to characterize the safety tolerability pharmacokinetics PK and pharmacodynamics PD of orally administered SKLB1028 as a single agent given daily for 28 days Cohorts of 3 patients receive SKLB1028 until dose limiting toxicity is noted DLT At that point cohorts will expand to 6 patients until MTD is determined Patients not experiencing DLT or significant disease progression could continue receiving SKLB1028 up to 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None