Phase 3
Completed N=74
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
Source: ClinicalTrials.gov NCT00952588 ↗Enrolled (actual)
74
Serious AEs
44.6%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Patients With Overall Complete Response for Stage I — 35.4; 11.5 percentage of participants
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.
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 | — |
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
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. Informational only — not medical advice.