Study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC)
Study identifier:D1531C00018
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, open-label, multi-centre, multiple ascending dose study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML)
Medical condition
Acute Myeloid Leukemia
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1152, LDAC (low dose cytosine arabinoside)
Sex
All
Actual Enrollment
4
Study type
Interventional
Age
60 Years +
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: 01 Aug 2010
Study Completion Date: 01 May 2011
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.) | Drug: AZD1152 Variable dose via a 7-day continuous infusion Drug: LDAC (low dose cytosine arabinoside) 20 mg subcutaneous injection given twice daily |
Contacts
Investigators
Principal Investigator
Paul Stockman
AstraZeneca
