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

This study is currently recruiting participants.

Verified by AstraZeneca, January 2010

First Received: June 22, 2009 Last Updated: January 14, 2010 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00926731

Purpose

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).

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: AZD1152 Drug: LDAC (low dose cytosine arabinoside)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cytarabine hydrochloride Cytarabine

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	18
Study Start Date:	June 2009
Estimated Study Completion Date:	October 2010

Arms	Assigned Interventions
1: Experimental 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

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926731

Contacts

Contact: Astrazeneca Cancer Study Locator Service, (US and CA only)

877-400-4656

astrazeneca@emergingmed.com

Locations

United States, Ohio
Research Site	Recruiting
Cleveland, Ohio, United States
United States, Texas
Research Site	Recruiting
Houston, Texas, United States
France
Research Site	Not yet recruiting
Villejuif Cedex, France
Research Site	Recruiting
Le Chesnay Cedex, France

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

Additional Information:

Cancer Study Locator (US and Canada only) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Paul K. Stockman, MBChB, PhD, Medical Science Director (Emerging Products Team II) )
Study ID Numbers:	D1531C00018
Study First Received:	June 22, 2009
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00926731 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Acute Myeloid Leukaemia (AML)

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Leukemia
Neoplasms
Therapeutic Uses
Cytarabine

ClinicalTrials.gov processed this record on February 08, 2010