Ignite Creation Date:
2024-05-06 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03388749
Status:
COMPLETED
Last Update Posted:
2023-01-20
First Post:
2017-12-25
Brief Title:
Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia AML
Sponsor:
Moleculin Biotech Inc
Organization:
Moleculin Biotech Inc
Study Overview
Official Title:
Phase 12 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia AML That is Refractory to or Relapsed After Induction Therapy
Status:
COMPLETED
Status Verified Date:
2023-01
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 multi-center open-label dose escalation study that will determine the maximum tolerated dose MTD and recommended Phase 2 dose RP2D of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after induction therapy
Detailed Description:
Enrollment will occur in cohorts of 3 subjects in a conventional 33 escalating dose design starting at a dose level of 120 mgm2day administered for 3 days Dose escalation will take place on the basis of safety assessments in sequential cohorts of 3 subjects each The initial cohort will receive 120 mgm2day for 3 days For Cohorts 1 2 3 4 and 5 dose escalation will occur in 30-mgm2day increments until subjects are enrolled at a 240-mgm2day dose For Cohorts 6 7 and 8 dose escalation will occur in 60-mgm2day increments until subjects are enrolled at a maximum dose of 420 mgm2day Thus subsequent cohorts will receive 150 180 210 240 300 360 and up to a maximum of 420 mgm2day for 3 days in the absence of safety concerns
In each cohort during the dose escalation phase if 1 of the 3 subjects experiences a DLT the cohort of subjects at that dose level will be expanded to 6 subjects If at least 2 of the 6 subjects experience a DLT this will be considered a toxic dose and the next 3 subjects will be treated at a lower dose The dose will be de-escalated in 30-mgm2day increments As such if at least 2 out of 6 subjects receiving 300 360 or 420 mgm2day experience a DLT the next 3 subjects will receive 270 330 or 390 mgm2day respectively The MTD is defined as the highest dose of L-Annamycin at which fewer than 2 of a cohort of up to 6 subjects experience a DLT
Once the MTDRP2D is identified up to 21 additional subjects will be enrolled at the MTDRP2D to better define toxicity and evaluate efficacy at this dose
In each cohort during the dose escalation phase if 1 of the 3 subjects experiences a DLT the cohort of subjects at that dose level will be expanded to 6 subjects If at least 2 of the 6 subjects experience a DLT this will be considered a toxic dose and the next 3 subjects will be treated at a lower dose The dose will be de-escalated in 30-mgm2day increments As such if at least 2 out of 6 subjects receiving 300 360 or 420 mgm2day experience a DLT the next 3 subjects will receive 270 330 or 390 mgm2day respectively The MTD is defined as the highest dose of L-Annamycin at which fewer than 2 of a cohort of up to 6 subjects experience a DLT
Once the MTDRP2D is identified up to 21 additional subjects will be enrolled at the MTDRP2D to better define toxicity and evaluate efficacy at this dose
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