Phase 3 N=74 Randomized Treatment

Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) Patients

Acute Myeloid Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00952588 ↗

Enrolled (actual)

Serious AEs

44.6%

Results posted

Mar 2014

Primary outcome: Primary: Percentage of Patients With Overall Complete Response for Stage I — 35.4; 11.5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: AZD1152 (Drug); LDAC (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Overall Complete Response for Stage I	35.4; 11.5	—
SECONDARY Duration of Response (DoR): Stage I and Transition Phase	82; NA	—
SECONDARY Disease Free Survival (DFS)	5.6; NA	—
SECONDARY Time To Complete Response (TTCR)	59; 64	—
SECONDARY Overall Survival (OS)	8.2; 4.5	—
SECONDARY Percent of Patients With Worsened Trial Outcome Index (TOI)	31.3; 11.5	—
SECONDARY Percent of Patients With Worsened Functional Assessment of Cancer Therapy - Leukaemia (FACT-Leu) Score.	29.2; 11.5	—

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.

Eligibility Criteria

Inclusion Criteria

Provision of written informed consent
Newly diagnosed male or female patients aged 60 and over
De Novo or Secondary AML
Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following:Age ≥75 years; Adverse cytogenetics, e.g., as defined by the MRC Prognostic Groupings; WHO performance status >2; Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia

Exclusion Criteria

Participation in another clinical study in which an investigational product was received within 14 days before the first dose in this study, or at any time if the patient has not recovered from side-effects associated with that investigational product
Administration of LDAC is clinically contraindicated
Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)
Patients with blast crisis of chronic myeloid leukaemia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00952588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.