Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)

Phase 1

Completed

• Conditions: Acute Myeloid Leukaemia

• Registration Number: NCT00530699
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia who are not considered to be suitable for standard chemotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-14
• Study First Posted: 2007-09-17
• Study Start: 2007-11
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-10
• Last Update Posted: 2009-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission
• Newly diagnosed Acute Myeloid Leukemia who are not considered suitable for other treatments.

Read More

Exclusion Criteria

• Administration of anticancer agents (other than hydroxyurea) within 2 weeks prior to first dose of study drug, and administration of hydroxyurea within 24 hours prior to first dose of study drug
• Participation in any other trial with an investigational product within the previous 30 days.
• Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To examine the pharmacokinetics of AZD1152	assessed after dose administration

Trial Locations

Locations (1)

Research Site; 🇯🇵 Fukuoka, Japan