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Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia

NCT ID: NCT00497991

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myeloid Leukemia

Keywords

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AML phase I/II AZD1152 Acute Myeloid Leukaemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AZD1152

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Paul Stockman, MD

Role: STUDY_DIRECTOR

AstraZeneca

Bob Lowenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute

Locations

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Research Site

New York, New York, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Angers, , France

Site Status

Research Site

Grenoble, , France

Site Status

Research Site

Le Chesnay, , France

Site Status

Research Site

Bologna, , Italy

Site Status

Research Site

Roma, , Italy

Site Status

Research Site

Amsterdam, , Netherlands

Site Status

Research Site

Nijmegen, , Netherlands

Site Status

Research Site

Rotterdam, , Netherlands

Site Status

Countries

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United States France Italy Netherlands

References

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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.

Reference Type DERIVED
PMID: 21976672 (View on PubMed)

Other Identifiers

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EUDRACT number 2005-004243-65

Identifier Type: -

Identifier Source: secondary_id

D1531C00007

Identifier Type: -

Identifier Source: org_study_id