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

June 15, 2011 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Chesnay Cedex, France
        • Research Site
      • Villejuif Cedex, France
        • Research Site
  • United States
    • Ohio
      • Cleveland, Ohio, United States
        • Research Site
    • Texas
      • Houston, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Information on these will be collected from the time of informed consent is signed, throughout the study.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 15, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1531C00018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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