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AZD1152

Phase 2

Acute Myeloid Leukemia | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Feb 24, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

AZD1152 · 5 trials · 3 indications

Phase 2 1Phase 1 4
NCT00952588Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) PatientsAcute Myeloid Leukemia
COMPLETED74 Analytics
PHASE2COMPLETED
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
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Patients With Overall Complete Response for Stage I
IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011)

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.

The concentration of total radioactivity, AZD1152 and AZD1152 hQPA in plasma and their ratios, the concentration of total radioactivity in blood and its blood/plasma concentration ratios
Day1-10
The derived plasma and urinary pharmacokinetic parameters for AZD1152 and AZD1152 hQPA The percentage of the [14C] AZD1152 dose recovered in urine, faeces and vomit (if presented), and the percentage of radioactive dose recovered overall.
Day1-10
Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis
Information on these will be collected from the time of informed consent is signed, throughout the study.
To assess the safety and tolerability of AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis
assessed at each visit
To assess the safety and tolerability of multiple ascending doses AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis.
Assessed at each visit
To determine the rate of complete remission from baseline changes in bone marrow and blood myeloblast counts and recovery of normal haemopoiesis
Change from baseline

Secondary Endpoints

Duration of Response (DoR): Stage I and Transition Phase
DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
Disease Free Survival (DFS)
DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
Time To Complete Response (TTCR)
Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD1152 1200 mgEXPERIMENTALAZD1152 1200 mg, iv, 7 day infusion monotherapy
LDAC 20 mgACTIVE_COMPARATORLDAC 20 mg, sc, bd, 10 days (400mg per cycle)
AZD1152EXPERIMENTAL100 mg Lyophile 5 mL Diluent
C14 AZD1152EXPERIMENTALAZD1152 radiolabelled IV solution. 1.05 mg/ml will be presented as a 15 ml fill in a 20 ml vial.
1EXPERIMENTALAZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)

Interventions

NameTypeDescription
AZD1152DRUG1200 mg, iv, 7 day infusion
LDACDRUG20 mg, sc, bd, 10 days
C14 AZD1152DRUGradiolabelled IV solution, 1.05 mg/ml presented as 15 ml fill in 20ml vial infusion
LDAC (low dose cytosine arabinoside)DRUG20 mg subcutaneous injection given twice daily
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites45

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...

Countries:United StatesAustraliaFranceGermanyItalyJapanRomaniaSpainUnited KingdomNetherlands
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Frequently asked questions about AZD1152

What is AZD1152 used for?

AZD1152 is an investigational small molecule being studied for the treatment of acute myeloid leukemia (AML), also referred to as myeloid leukemia or acute myeloid leukaemia. It is being developed by AstraZeneca PLC (AZN) and has been evaluated in clinical trials for this hematologic malignancy.

What does AZD1152 target?

AZD1152 is a small molecule that targets aurora kinase B, an enzyme involved in cell division. By inhibiting this target, it is intended to disrupt the proliferation of cancer cells in acute myeloid leukemia. This mechanism is being investigated in clinical trials for the treatment of AML.

Who makes AZD1152?

AZD1152 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of AZD1152 in patients with acute myeloid leukemia.

What phase is AZD1152 in?

AZD1152 is in Phase 1 clinical development. It has completed Phase 1 trials, and there are no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities for the treatment of acute myeloid leukemia.

What clinical trials is AZD1152 in?

AZD1152 has been studied in several completed clinical trials, including NCT00530699, a Phase 1 safety and tolerability study in patients with relapsed acute myeloid leukemia in Japan, and NCT00926731, a Phase 1 study combining AZD1152 with low dose cytosine arabinoside in the United States and France. Additional trials include NCT00952588 and NCT01019161.

Is AZD1152 the same as barasertib?

AZD1152 is also known as barasertib, a prodrug that is converted to its active form in the body. It is being investigated for the treatment of acute myeloid leukemia. The drug has been evaluated in clinical trials under the name AZD1152, and barasertib is the alternative name used in some contexts.