Ignite Creation Date:
2024-05-05 @ 11:59 PM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01468467
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2011-11-07
Brief Title:
A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia AML
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 1 Study of AC220 ASP2689 as Maintenance Therapy in Subjects With Acute Myeloid Leukemia Who Have Been Treated With an Allogeneic Hematopoietic Stem Cell Transplant
Status:
COMPLETED
Status Verified Date:
2016-11
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:
The purpose of this study is to define a safe dose of AC220 when given as maintenance therapy after treatment with an allogeneic stem cell transplant
Detailed Description:
This is a two-part sequential group dose escalation study
In Part 1 subjects will be enrolled into successive cohorts to determine the maximum tolerated dose MTD Dose escalation decision will be made based on dose limiting toxicities DLTs that occur in subjects treated to date at a given dose level In Part 2 a confirmation cohort will be opened to confirm the safety at the MTD
Subjects who have had an allogeneic Hematopoietic Stem Cell Transplant HSCT will enter treatment with AC220 between 30 to 60 days after receiving allogeneic HSCT AC220 will be administered every day with 28 consecutive days defined as a treatment cycle Subjects may receive up to 24 continuous treatment cycles Subjects will have study visits each week for the first 2 cycles and then on Day 1 of each cycle after that
In Part 1 subjects will be enrolled into successive cohorts to determine the maximum tolerated dose MTD Dose escalation decision will be made based on dose limiting toxicities DLTs that occur in subjects treated to date at a given dose level In Part 2 a confirmation cohort will be opened to confirm the safety at the MTD
Subjects who have had an allogeneic Hematopoietic Stem Cell Transplant HSCT will enter treatment with AC220 between 30 to 60 days after receiving allogeneic HSCT AC220 will be administered every day with 28 consecutive days defined as a treatment cycle Subjects may receive up to 24 continuous treatment cycles Subjects will have study visits each week for the first 2 cycles and then on Day 1 of each cycle after that
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