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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00926731

First received: June 22, 2009

Last updated: June 15, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 22, 2009

Last Updated Date

June 15, 2011

Start Date ^ICMJE

June 2009

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis [ Time Frame: Information on these will be collected from the time of informed consent is signed, throughout the study. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00926731 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Myeloid Leukemia

Intervention ^ICMJE

Drug: AZD1152
Variable dose via a 7-day continuous infusion
Drug: LDAC (low dose cytosine arabinoside)
20 mg subcutaneous injection given twice daily

Study Arm (s)

Experimental: 1

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

Interventions:

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

Publications *

Quintás-Cardama A, Ravandi F, Liu-Dumlao T, Brandt M, Faderl S, Pierce S, Borthakur G, Garcia-Manero G, Cortes J, Kantarjian H. Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia. Blood. 2012 Dec 6;120(24):4840-5. doi: 10.1182/blood-2012-06-436055. Epub 2012 Oct 15.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2011

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France

Administrative Information

NCT Number ^ICMJE

NCT00926731

Other Study ID Numbers ^ICMJE

D1531C00018

Has Data Monitoring Committee

Not Provided

Responsible Party

Paul K. Stockman, MBChB, PhD, Medical Science Director (Emerging Products Team II), AstraZeneca Pharmaceuticals

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Paul Stockman	AstraZeneca
Principal Investigator:	Hagop Kantarjian	M. D. Anderson, (University of Texas)

Information Provided By

AstraZeneca

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top