Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00952588 | Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) Patients | PHASE2 | COMPLETED | 74 | — | — | Jul 1, 2009 | Jun 1, 2011 | Feb 24, 2020 | 45 | United States, Australia +7 |
| NCT00926731 | Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC) | PHASE1 | COMPLETED | 4 | — | — | Jun 1, 2009 | May 1, 2011 | Jun 16, 2011 | 4 | United States, France |
Percentage of patients achieving either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi). Per Cheson Criteria: Confirmed complete remission (CRi) is defined as a disappearance of blasts in the peripheral blood; a decrease in bone marrow blasts to \<5% total bone marrow nucleated cells demonstrated in bone marrow aspirate; absence of Auer rods; no persistent extramedullary leukaemia. Complete response (CR) is defined as all requirements to meet CRi and in addition: recovery of neutrophils to ≥1.0 x 109/L and platelets to ≥100 x 109/L; transfusion-independence.
| Arm | Type | Description |
|---|---|---|
| AZD1152 1200 mg | EXPERIMENTAL | AZD1152 1200 mg, iv, 7 day infusion monotherapy |
| LDAC 20 mg | ACTIVE_COMPARATOR | LDAC 20 mg, sc, bd, 10 days (400mg per cycle) |
| 1 | EXPERIMENTAL | AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.) |
| Name | Type | Description |
|---|---|---|
| AZD1152 | DRUG | 1200 mg, iv, 7 day infusion |
| LDAC | DRUG | 20 mg, sc, bd, 10 days |
| LDAC (low dose cytosine arabinoside) | DRUG | 20 mg subcutaneous injection given twice daily |
Inclusion Criteria: * Provision of written informed consent * Newly diagnosed male or female patients aged 60 and over * De Novo or Secondary AML * Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following:Age ≥75 years; Adve...