NCT00497991

Brief Summary

The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2006

Longer than P75 for phase_1

Geographic Reach
4 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2010

Enrollment Period

3.4 years

First QC Date

July 5, 2007

Last Update Submit

December 7, 2010

Conditions

Myeloid Leukemia

Keywords

AMLphase I/IIAZD1152Acute Myeloid Leukaemia

Outcome Measures

Primary Outcomes (2)

  • To assess the safety and tolerability of multiple ascending doses AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis.

    Assessed at each visit

  • To determine the rate of complete remission from baseline changes in bone marrow and blood myeloblast counts and recovery of normal haemopoiesis

    Change from baseline

Secondary Outcomes (1)

  • To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability

    Assessed at each visit

Interventions

AZD1152DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission
  • Newly diagnosed AML who are not considered suitable for other treatments.

You may not qualify if:

  • Previous myeloablative therapy allogeneic bone marrow or stem cell transplantation, radiotherapy or chemotherapy within 4 weeks of first dose.
  • Participation in any other trial with an investigational product within the previous 30 days
  • Other active malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

New York, New York, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Angers, France

Location

Research Site

Grenoble, France

Location

Research Site

Le Chesnay, France

Location

Research Site

Bologna, Italy

Location

Research Site

Roma, Italy

Location

Research Site

Amsterdam, Netherlands

Location

Research Site

Nijmegen, Netherlands

Location

Research Site

Rotterdam, Netherlands

Location

Related Publications (1)

  • Lowenberg B, Muus P, Ossenkoppele G, Rousselot P, Cahn JY, Ifrah N, Martinelli G, Amadori S, Berman E, Sonneveld P, Jongen-Lavrencic M, Rigaudeau S, Stockman P, Goudie A, Faderl S, Jabbour E, Kantarjian H. Phase 1/2 study to assess the safety, efficacy, and pharmacokinetics of barasertib (AZD1152) in patients with advanced acute myeloid leukemia. Blood. 2011 Dec 1;118(23):6030-6. doi: 10.1182/blood-2011-07-366930. Epub 2011 Oct 5.

    PMID: 21976672DERIVED

MeSH Terms

Conditions

Leukemia, MyeloidLeukemia, Myeloid, Acute

Interventions

2-((3-((4-((5-(2-((3-fluorophenyl)amino)-2-oxoethyl)-1H-pyrazol-3-yl)amino)quinazolin-7-yl)oxy)propyl)(ethyl)amino)ethyl dihydrogen phosphate

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Paul Stockman, MD

    AstraZeneca

    STUDY DIRECTOR

  • Bob Lowenberg, MD, PhD

    Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 9, 2007

Study Start

May 1, 2006

Primary Completion

October 1, 2009

Study Completion

April 1, 2010

Last Updated

December 8, 2010

Record last verified: 2010-12

Locations

IT(2)NL(3)FR(3)US(2)