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NCT00497991 Clinical Trial

Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia

Myeloid Leukemia Clinical Trial

Official title:
A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00497991
Other study ID # D1531C00007
Secondary ID EUDRACT number 2
Status Completed
Phase Phase 1
First received July 5, 2007
Last updated December 7, 2010
Start date May 2006
Est. completion date April 2010

Study information
Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date April 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission

- Newly diagnosed AML who are not considered suitable for other treatments.

Exclusion Criteria:

- Previous myeloablative therapy allogeneic bone marrow or stem cell transplantation, radiotherapy or chemotherapy within 4 weeks of first dose.

- Participation in any other trial with an investigational product within the previous 30 days

- Other active malignancy.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AZD1152

Locations
Country Name City State
France Research Site Angers Cedex
France Research Site Grenoble Cedex
France Research Site Le Chesnay Cedex
Italy Research Site Bologna
Italy Research Site Roma
Netherlands Research Site Amsterdam
Netherlands Research Site Nijmegen
Netherlands Research Site Rotterdam
United States Research Site Houston Texas
United States Research Site New York New York

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  France,  Italy,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability Assessed at each visit
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