Ignite Creation Date:
2024-05-05 @ 11:42 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01390337
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2011-07-07
Brief Title:
A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia AML
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 1 Study of AC220 ASP2689 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2015-10
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:
The purpose of this study is to define the maximum tolerated dose MTD of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation
Detailed Description:
Subjects will receive escalating doses of AC220 plus standard 73 cytarabine and daunorubicin remission induction therapy Subjects may receive up to 2 cycles of induction therapy Subjects who have a complete response including complete remission CR with incomplete hematologic recovery are eligible to receive up to 3 consolidation cycles In consolidation subjects will receive AC220 plus high dose cytarabine Subjects achieving a composite Complete Remission CRc will be eligible to receive AC220 alone for up to 12 additional 28 day cycles
Subjects will be enrolled into successive gender balanced cohorts of 6 subjects at least 3 must be females to determine the maximum tolerated dose MTD Dose escalation decision will be made based on dose limiting toxicities DLTs that occur during the first remission induction cycle Seven and 14 day schedules will be evaluated
After the MTD and schedule is established the study will open to enroll between 14 to 34 subjects Subjects will receive AC220 during induction and consolidation at the MTD and schedule established Stopping rules will be used to evaluate safety at the current dose If testing at a dose level must be stopped then a lower dose may be tested MTD will also be established for the maintenance therapy
Subjects will be enrolled into successive gender balanced cohorts of 6 subjects at least 3 must be females to determine the maximum tolerated dose MTD Dose escalation decision will be made based on dose limiting toxicities DLTs that occur during the first remission induction cycle Seven and 14 day schedules will be evaluated
After the MTD and schedule is established the study will open to enroll between 14 to 34 subjects Subjects will receive AC220 during induction and consolidation at the MTD and schedule established Stopping rules will be used to evaluate safety at the current dose If testing at a dose level must be stopped then a lower dose may be tested MTD will also be established for the maintenance 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