Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: AZD1152; Drug: LDAC (low dose cytosine arabinoside)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00926731

D1531C00018

Details and patient eligibility

About

A study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.

Enrollment: 4 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed patient.
• Provision of written informed consent.
• De Novo (primary) or Secondary AML.
• Not eligible for intensive induction chemotherapy because of medical, social or psychological reasons.

Exclusion criteria

• Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL).
• Patients with blast crisis of chronic myeloid leukaemia.
• Persistent, chronic, clinically significant toxicities from any prior anti- cancer therapy greater than CTCAE Grade 1 (except alopecia).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

1

Experimental group

Description:

AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)

Treatment:

Drug: AZD1152

Drug: LDAC (low dose cytosine arabinoside)