Ignite Creation Date:
2024-05-06 @ 12:47 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01657682
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2012-07-31
Brief Title:
A Phase II Study of Crenolanib in RelapsedRefractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
Sponsor:
Arog Pharmaceuticals Inc
Organization:
Arog Pharmaceuticals Inc
Study Overview
Official Title:
A Phase II Study of Crenolanib in RelapsedRefractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This pilot Phase II study is designed to evaluate the efficacy and tolerability of crenolanib in two cohorts of AML patients with FLT3 activation mutations patients whose leukemia has recurred after prior chemotherapy not including a FLT3 TKI and patients whose leukemia has progressed after prior therapy with a FLT3 TKI
Detailed Description:
This is a Phase II open label study of crenolanib besylate This study will enroll subjects with relapsed acute myeloid leukemia AML with FLT3 activating mutations Two cohorts of patients will be enrolled those whose AML has recurred after prior chemotherapy without a FLT3 TKI and those whose AML has progressed after prior therapy with FLT3 TKIs Subjects will take Crenolanib besylate at 100 mg TID until disease progression death or unacceptable toxicities Concurrent hydroxyurea is permitted during the first 28 days of study therapy
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