Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462761
Status:
COMPLETED
Last Update Posted:
2020-05-11
First Post:
2007-04-17
Brief Title:
A Phase I Study of AC220 in Patients With RelapsedRefractory Acute Myeloid Leukemia Regardless of FLT3 Status
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
Phase I Open-Label Sequential Dose Escalation Study Investigating the Safety Tolerability Pharmacokinetics and Pharmacodynamics of AC220 When Administered Daily to Patients With Relapsed or Refractory Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2020-04
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:
Patients received oral AC220 daily for 14 days to study the side effects tolerability and best dose for treating relapsed or refractory acute myeloid leukemia regardless of FLT3 status
Detailed Description:
This is a multi-center clinical study conducted in the USA and two international sites This open-label dose escalation study was designed to characterize the safety tolerability pharmacokinetics PK and pharmacodynamics PD of orally administered AC220 as a single agent given daily for 14 days Cohorts of 3 patients received AC220 until dose limiting toxicity was noted DLT At that point cohorts expanded to 6 patients until MTD was determined Patients not experiencing DLT or significant disease progression at Day 15 may have continued receiving AC220 at the discretion of the Investigator and Sponsor FLT3 positive and negative patients were allowed to participate
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