Clinical trial NCT00926731: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukaemia (AML)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-24
Enrollment: 4
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis
timeFrame: Information on these will be collected from the time of informed consent is signed, throughout the study.
Secondary outcomes:
measure: Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC.
timeFrame: 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.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Houston
country: United States
facility: Research Site
state: Texas
city: Le Chesnay Cedex
country: France
facility: Research Site
city: Villejuif Cedex
country: France
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Paul Stockman
role: STUDY_DIRECTOR
affiliation: M. D. Anderson, (University of Texas)
name: Hagop Kantarjian
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.