Clinical trial NCT00497991: Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia
Official title: A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myeloid Leukemia
Keywords: AML
phase I/II
AZD1152
Acute Myeloid Leukaemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-09
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Assessed at each visit
measure: To determine the rate of complete remission from baseline changes in bone marrow and blood myeloblast counts and recovery of normal haemopoiesis
timeFrame: Change from baseline
Secondary outcomes:
measure: To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability
timeFrame: Assessed at each visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Site
state: New York
city: Houston
country: United States
facility: Research Site
state: Texas
city: Angers Cedex
country: France
facility: Research Site
city: Grenoble Cedex
country: France
facility: Research Site
city: Le Chesnay Cedex
country: France
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Paul Stockman, MD
role: STUDY_DIRECTOR
affiliation: Cancer Institute
name: Bob Lowenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.