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

Primary Purpose

Acute Myeloid Leukemia

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AZD1152

LDAC (low dose cytosine arabinoside)

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukaemia (AML)

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis

Secondary Outcome Measures

Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC.

Full Information

NCT ID

NCT00926731

First Posted

June 22, 2009

Last Updated

June 15, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00926731

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukaemia (AML)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AZD1152

Intervention Description

Variable dose via a 7-day continuous infusion

Intervention Type

Drug

Intervention Name(s)

LDAC (low dose cytosine arabinoside)

Intervention Description

20 mg subcutaneous injection given twice daily

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Stockman

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hagop Kantarjian

Organizational Affiliation

M. D. Anderson, (University of Texas)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Cleveland

State/Province

Ohio

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Le Chesnay Cedex

Country

France

Facility Name

Research Site

City

Villejuif Cedex

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

23763917

Citation

Kantarjian HM, Sekeres MA, Ribrag V, Rousselot P, Garcia-Manero G, Jabbour EJ, Owen K, Stockman PK, Oliver SD. Phase I study assessing the safety and tolerability of barasertib (AZD1152) with low-dose cytosine arabinoside in elderly patients with AML. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):559-67. doi: 10.1016/j.clml.2013.03.019. Epub 2013 Jun 10.

Results Reference

derived

PubMed Identifier

23071272

Citation

Quintas-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.

Results Reference

derived

Learn more about this trial

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

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