Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04842370
Status:
UNKNOWN
Last Update Posted:
2021-04-20
First Post:
2021-04-08
Brief Title:
Evaluation of the Safety Tolerability Pharmacokinetics and Pharmacodynamics of PHI 101 for the Treatment of AML
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
A Prospective Phase IaIb Multicenter Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of the FLT3 Inhibitor PHI 101 Alone in Subjects With Relapsed or Refractory Acute Myeloid Leukemia AML
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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 find out the maximum tolerable dose and safety of PHI-101 novel FLT3 inhibitor in the treatment of relapsed or refractory AML for patients who have received standard therapy or cannot tolerate standard therapy andor for whom no standard therapy exists
There will be two parts to the study which we will call Phase Ia and Phase Ib Phase Ia is called the dose escalation Approximately 20 to 24 patients are planned to be enrolled into Phase Ia Phase 1a is conducted to determine the best dose and schedule of dosing of PHI-101 to be used in Phase 1b There will be 5 different dose levels of PHI-101 given to patients in Phase Ia
Phase Ib is called the dose expansion Approximately 14-34 patients approximately 14-17 patients in each of the 2 cohorts planned of each cohort are planned in Phase Ib based on study design Phase Ib is also being conducted to assess anti-leukemia response changes in transfusion requirements and safety of PHI-101 at the dose level identified during Phase Ia
There will be two parts to the study which we will call Phase Ia and Phase Ib Phase Ia is called the dose escalation Approximately 20 to 24 patients are planned to be enrolled into Phase Ia Phase 1a is conducted to determine the best dose and schedule of dosing of PHI-101 to be used in Phase 1b There will be 5 different dose levels of PHI-101 given to patients in Phase Ia
Phase Ib is called the dose expansion Approximately 14-34 patients approximately 14-17 patients in each of the 2 cohorts planned of each cohort are planned in Phase Ib based on study design Phase Ib is also being conducted to assess anti-leukemia response changes in transfusion requirements and safety of PHI-101 at the dose level identified during Phase Ia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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