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

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). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: AZD1152 Drug: LDAC (low dose cytosine arabinoside)	Phase 1

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

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: 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 ]

Enrollment:	4
Study Start Date:	June 2009
Study Completion Date:	May 2011
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

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

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

Locations

United States, Ohio
Research Site
Cleveland, Ohio, United States
United States, Texas
Research Site
Houston, Texas, United States
France
Research Site
Le Chesnay Cedex, France
Research Site
Villejuif 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:	Paul K. Stockman, MBChB, PhD, Medical Science Director (Emerging Products Team II), AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00926731 History of Changes
Other Study ID Numbers:	D1531C00018
Study First Received:	June 22, 2009
Last Updated:	June 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Acute Myeloid Leukaemia (AML)

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2012