Ignite Creation Date:
2024-05-06 @ 10:13 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03194685
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2017-05-04
Brief Title:
Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
Fujifilm Pharmaceuticals USA Inc
Organization:
Fujifilm Pharmaceuticals USA Inc
Study Overview
Official Title:
A First-in-Human Phase 12a Study to Assess the Safety Tolerability Efficacy and Pharmacokinetics of FF-10101-01 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2022-04
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:
A Phase 12a dose escalation and dose ranging study of FF-10101-01 in subjects with relapsed or refractory acute myeloid leukemia to determine the safety tolerability PK and preliminary efficacy A total of 9 cohorts will be enrolled in Phase 1 to establish the Maximum Tolerated Dose MTD Phase 2a will consist of up to 3 dose levels high medium and low of which subjects with FLT3 mutations will randomly be assigned
Detailed Description:
Subjects will receive FF-10101-01 orally once a day repeated every 28 days 1 cycle Frequent blood draws will be collected to measure pharmacodynamic parameters and pharmacodynamic activity
Disease assessments including bone marrow aspirates will be performed at the beginning of cycles 1-3 and every 3 months thereafter Subjects who demonstrate objective response or stable disease will be allowed to continue therapy with FF-10101-01 until observation of unacceptable adverse events or until the subject is no longer deriving benefit based on the opinion of the investigator
For Phase 2a long term phone follow-up for assessment of overall survival will also occur
Disease assessments including bone marrow aspirates will be performed at the beginning of cycles 1-3 and every 3 months thereafter Subjects who demonstrate objective response or stable disease will be allowed to continue therapy with FF-10101-01 until observation of unacceptable adverse events or until the subject is no longer deriving benefit based on the opinion of the investigator
For Phase 2a long term phone follow-up for assessment of overall survival will also occur
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None