Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05947344
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2023-06-25
Brief Title:
A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia AML
Sponsor:
Zhejiang ACEA Pharmaceutical Co Ltd
Organization:
Zhejiang ACEA Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multicenter Open Dose Escalation and Dose Expansion Phase I Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of STI-8591 in Subjects With Advanced Acute Myeloid Leukemia AML
Status:
RECRUITING
Status Verified Date:
2024-01
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:
This is a first-in-human dose-escalation and dose-expansion Phase I study to evaluate the safety tolerability pharmacokinetics PK and efficacy of STI-8591 in subjects with advanced AML who have signed an informed consent form ICF and have been screened for enrollment in this study
Dose escalation phase rapid titration and conventional 33 test design were used to evaluate the safety dose-limiting toxicity DLT maximum tolerated dose MTD and PK characteristics of STI-8591
Dose Expansion Phase Evaluate the safety preliminary efficacy and determine the recommended phase II dose RP2D of STI-8591 for the treatment of subjects with advanced AML under the conditions of reaching the expanded dose
Dose escalation phase rapid titration and conventional 33 test design were used to evaluate the safety dose-limiting toxicity DLT maximum tolerated dose MTD and PK characteristics of STI-8591
Dose Expansion Phase Evaluate the safety preliminary efficacy and determine the recommended phase II dose RP2D of STI-8591 for the treatment of subjects with advanced AML under the conditions of reaching the expanded dose
Detailed Description:
Dose escalation phaseBased on the preclinical trial data and with reference to the modified Fibonacci method the dose escalation ratios are 100 100 50 and 67 and the initial 5 dose groups for STI-8591 dose escalation are 40 80 160 240 and 280 mgday respectively Screened subjects will be entered into the 5 dose groups in order of succession from lowest to highest doseThis test dose increment will be performed using the rapid titration method and the traditional 33 test design
Dose expansion phaseDuring dose escalation for dose groups except for 2 DLT dose groups when the following dose signals suggesting initial efficacy are present
1 CR CRh or CRi in 1 subject in either dose group2 Median decrease in FLT3 phosphorylation was 90 in 3 subjects in either dose groupThe SRC will decide whether to initiate an extension study for that dose group and its subsequent dose groups at the same time as the dose escalation to the next dose group Subjects in the dose escalation phase will be administered BID every 28 days in 1 cycle with 8h between doses fasting for at least 2 hours before and at least 1 hour after dosing with approximately 240mL of water subject to adjustment based on data results from the dose escalation phase If initiation was determined the dose group identified for initiation and its subsequent dose group extension studies were further enrolled in 14 to 17 cases a total of 20 cases in each dose group with FLT3 mutation-positive FLT3 internal tandem repeat ITD andor FLT3 tyrosine kinase structural domain TKD mutation-positive subjects enrolled in at least 10 cases to further define the final RP2D
Dose expansion phaseDuring dose escalation for dose groups except for 2 DLT dose groups when the following dose signals suggesting initial efficacy are present
1 CR CRh or CRi in 1 subject in either dose group2 Median decrease in FLT3 phosphorylation was 90 in 3 subjects in either dose groupThe SRC will decide whether to initiate an extension study for that dose group and its subsequent dose groups at the same time as the dose escalation to the next dose group Subjects in the dose escalation phase will be administered BID every 28 days in 1 cycle with 8h between doses fasting for at least 2 hours before and at least 1 hour after dosing with approximately 240mL of water subject to adjustment based on data results from the dose escalation phase If initiation was determined the dose group identified for initiation and its subsequent dose group extension studies were further enrolled in 14 to 17 cases a total of 20 cases in each dose group with FLT3 mutation-positive FLT3 internal tandem repeat ITD andor FLT3 tyrosine kinase structural domain TKD mutation-positive subjects enrolled in at least 10 cases to further define the final RP2D
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