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

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: AZD1152; Drug: LDAC (low dose cytosine arabinoside)

• Registration Number: NCT00926731
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-23
• Study First Posted: 2009-06-24
• Primary Completion: 2010-08
• Study Completion: 2011-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-15
• Last Update Posted: 2011-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD1152	AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)
1	LDAC (low dose cytosine arabinoside)	AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC.	During the first treatment cycle for AZD1152, pre-dose and Days 2, 3,7, 8, 9, 10, 15 and 22. For LDAC, Days 7 and 10.

Trial Locations

Locations (1)

Research Site; 🇫🇷 Villejuif Cedex, France