Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01349049
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2011-05-04
Brief Title:
Phase 12 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia AML
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 12 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory FLT3-ITD Positive Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2020-02
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 evaluate the safety of study drug PLX3397 at 3 dose levels 800 mgday 1000 mgday and 1200 mgday and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia AML Additional dose levels beyond 1200 mgday may be considered based on safety and efficacy observations
Detailed Description:
Protocol PLX108-05 is a Phase 12 open-label sequential dose escalation Part 1 followed by cohort expansion Part 2 design at the recommended phase 2 dose established in Part 1 ie 3000 mgday Treatment with PLX3397 will consist of continuous oral administration in 28-day cycles until unacceptable or dose-limiting toxicity disease progression or relapse patient death Investigator decision or voluntary withdrawal
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