Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05319587
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2022-02-22
Brief Title:
Study of Liposomal Annamycin in Combination With Cytarabine 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 in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia AML
Status:
RECRUITING
Status Verified Date:
2023-06
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 Phase 12 multicenter open-label dose-escalation study that will determine the MTD and RP2D of L-Annamycin in combination with cytarabine for the treatment of subjects with AML
Detailed Description:
During Phase 1b dose escalation will proceed according to a standard 33 design An initial group of 3 subjects will be treated with an intravenous infusion of 190-mgm2 L-Annamycin Dose Level 1 for 3 consecutive days Dose escalation will take place on the basis of safety assessments in sequential cohorts of 3 subjects each Provided that there are no DLTs in the initial cohort of subjects treated at the 190 mgm2day dose level the next cohort of subjects will receive the next highest L-Annamycin dose incremented by 40 mgm2 In the absence of DLTs dose escalation by 40 mgm2 will continue in subsequent cohorts until an MTD is reached
The dose and schedule of cytarabine during Cycle 1 20 gm2day for 5 consecutive days will remain constant for all cohorts Enrolled subjects will receive cytarabine at a dose of 20 gm2day via intravenous infusion over 4 hours for 5 consecutive days total dose cytarabine 100 gm2 starting on the first day of L-Annamycin treatment
If no subject experiences a dose-limiting toxicity DLT based on National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE v5 which constitutes a study drug-related irreversible or not medically manageable Grade 3 or higher toxicity during the initial treatment through Day 28 the subsequent group of 3 subjects will receive the next higher L-Annamycin dose However if 1 of the 3 initial subjects experiences a DLT the cohort of subjects at that dose level will be expanded to 6 If at least 2 of the 6 subjects experience a DLT this will be considered a non-tolerated dose and the next 3 subjects will be treated at a lower dose The dose of L-Annamycin will be de-escalated by 20- mgm2day As such if at least 2 out of 6 subjects receiving 230 mgm2day experience a DLT the next 3 subjects will receive L-Annamycin at a dose of 210 mgm2day If 1 of the 3 initial subjects experiences a DLT the cohort of subjects 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 MTD will be the previously proven safe dose level ie the next lowest dose level at which no DLTs occurred in a cohort of 3 subjects or at which fewer than 2 subjects in a cohort of 6 experienced a DLT
In the expansion phase up to 21 subjects will be enrolled at the MTDRP2D to better define toxicity and evaluate efficacy
The dose and schedule of cytarabine during Cycle 1 20 gm2day for 5 consecutive days will remain constant for all cohorts Enrolled subjects will receive cytarabine at a dose of 20 gm2day via intravenous infusion over 4 hours for 5 consecutive days total dose cytarabine 100 gm2 starting on the first day of L-Annamycin treatment
If no subject experiences a dose-limiting toxicity DLT based on National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE v5 which constitutes a study drug-related irreversible or not medically manageable Grade 3 or higher toxicity during the initial treatment through Day 28 the subsequent group of 3 subjects will receive the next higher L-Annamycin dose However if 1 of the 3 initial subjects experiences a DLT the cohort of subjects at that dose level will be expanded to 6 If at least 2 of the 6 subjects experience a DLT this will be considered a non-tolerated dose and the next 3 subjects will be treated at a lower dose The dose of L-Annamycin will be de-escalated by 20- mgm2day As such if at least 2 out of 6 subjects receiving 230 mgm2day experience a DLT the next 3 subjects will receive L-Annamycin at a dose of 210 mgm2day If 1 of the 3 initial subjects experiences a DLT the cohort of subjects 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 MTD will be the previously proven safe dose level ie the next lowest dose level at which no DLTs occurred in a cohort of 3 subjects or at which fewer than 2 subjects in a cohort of 6 experienced a DLT
In the expansion phase up to 21 subjects will be enrolled at the MTDRP2D to better define toxicity and evaluate efficacy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005493-10 | EUDRACT_NUMBER | None | None |