Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Liposomal Annamycin, Liposomal Annamycin (L-Annamycin)
Annamycin · 5 trials · 4 indications
1\. To identify the optimal dosage regimen of L Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) as second line therapy for remission induction in adult subjects with refractory/relapsed acute myeloid leukemia (AML) as measured by rate of complete remission (CR) after one treatment cycle.
To confirm the superior efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by rate of CR after one treatment cycle
The number of patients who experience dose-limiting toxicities (DLT) will be captured at each dose level of LAnnamycin in order to determine the MTD/RP2D
Number of patients with a dose limiting toxicity (DLT) at each dose evaluated
The number of patients who experience dose-limiting toxicities (DLT) will be captured at each dose level of L-Annamycin in order to determine the MTD/RP2D
Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated
| Arm | Type | Description |
|---|---|---|
| Part A / Treatment Arm 1 | PLACEBO_COMPARATOR | placebo (0.9% Sodium Chloride Injection, i.e., the diluent for L-Annamycin for Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days |
| Part A / Treatment Arm 2 | ACTIVE_COMPARATOR | 190 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days. |
| Part A / Treatment Arm 3 | ACTIVE_COMPARATOR | 230 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days. |
| Part B / Treatment Arm 1 | PLACEBO_COMPARATOR | Placebo (0.9% Sodium Chloride Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 1 of Part A). |
| Part B / Treatment Arm X | ACTIVE_COMPARATOR | Optimal dosage regimen (as determined in Part A) of L Annamycin for Injection (190 mg/m2/day or 230 mg/m2/day) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 2 or 3, respectively, of Part A). |
| Liposomal annamycin | EXPERIMENTAL | - |
| Liposomal Annamycin (L-Annamycin) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo in combination with Cytarabine Injection | DRUG | placebo (0.9% Sodium Chloride Injection, i.e., the diluent for L-Annamycin for Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days. |
| Liposomal Annamycin Injection in combination with Cytarabine Injection | DRUG | 190 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days. |
| Liposomal Annamycin for Injection in combination with Cytarabine Injection. | DRUG | optimal dosage regimen (as determined in Part A) of L Annamycin for Injection (190 mg/m2/day or 230 mg/m2/day) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 2 or 3, respectively, of Part A). |
| Liposomal Annamycin | DRUG | 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days). |
| Cytarabine | DRUG | Administered during cycle 1 at a dose of 2.0 g/m2/day by 4 hours IV infusion for 5 consecutive days and this dose will remain constant for all cohorts, including the expansion phase. |
| Liposomal Annamycin (L-Annamycin) | DRUG | 2-hour intravenous (IV) infusion of L-Annamycin on Day 1 followed by 20 days off of study drug (i.e., 1 treatment cycle= 21 days) |
Inclusion Criteria: 1. Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) as adopted in the European LeukemiaNet (ELN) 2022 recommendations for the diagnosis and management of AML. The tests and procedures used to establish the diagnosis of AML...