Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) Patients - Full Text View

Purpose

The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: AZD1152 Drug: LDAC Drug: AZD1152 + LDAC	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomised, Open-label, Multi-centre, 2-stage, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC) in Comparison With LDAC Alone in Patients Aged ≥ 60 With Newly Diagnosed 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:

Overall Complete Response Rate: Defined as the proportion of patients achieving a Complete Remission or Complete Remission with incomplete recovery of neutrophils and platelets [ Time Frame: Day 1 Predose and day 28 of each cycle, treatment stop and follow-up visits. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability of AZD1152, alone and in combination with LDAC, compared to LDAC alone [ Time Frame: Information on this will be collected from the time informed consent is signed, throughout the study duration. ] [ Designated as safety issue: No ]
Assessment of Overall Survival, Duration of Response, Disease Free Survival and Time to Complete Response. [ Time Frame: Day 1 Predose, day 28, treatment stop and follow-up visit of each cycle. ] [ Designated as safety issue: No ]

Estimated Enrollment:	417
Study Start Date:	July 2009
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AZD1152 1200 mg	Drug: AZD1152 1200 mg, iv, 7 day infusion
Active Comparator: 2 LDAC 20 mg	Drug: LDAC 20 mg, sc, bd, 10 days
Experimental: 3 AZD1152 + LDAC	Drug: AZD1152 + LDAC Dose dependant upon parallel study D1531C00018

Eligibility

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

Criteria

Inclusion Criteria:

Provision of written informed consent
Newly diagnosed male or female patients aged 60 and over
De Novo or Secondary AML
Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following:Age ≥75 years; Adverse cytogenetics, e.g., as defined by the MRC Prognostic Groupings; WHO performance status >2; Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia

Exclusion Criteria:

Participation in another clinical study in which an investigational product was received within 14 days before the first dose in this study, or at any time if the patient has not recovered from side-effects associated with that investigational product
Administration of LDAC is clinically contraindicated
Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)
Patients with blast crisis of chronic myeloid leukaemia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952588

Show 45 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Paul Stockman	AstraZeneca
Principal Investigator:	Hagop Kantarjian	M.D. Anderson Cancer Center

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00952588 History of Changes
Other Study ID Numbers:	D1531C00009
Study First Received:	August 4, 2009
Last Updated:	October 9, 2012
Health Authority:	United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: Ethics Committee Italy: The Italian Medicines Agency Spain: Comité Ético de Investigación Clínica Spain: Spanish Agency of Medicines Australia: Department of Health and Ageing Therapeutic Goods Administration Japan: Ministry of Health, Labor and Welfare Romania: National Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 21, 2013

Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) Patients (SPARK-AML1)