Acute Leukaemia Cancer Acute lymphoblastic & acute myeloid leukaemia
Conditions
Interventions
Blood and tissue sampling, as per protocol schedule for the purposes of safety, disease assessment, pharmacokinetic and pharmacodynamic analysis. Disease assessment, According to the reposne criteria
Treatment with AT9283, 72 hour infusion every 21 days.
Sponsors
Cancer Research UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Morhologically proven acute lymphoblastic or acute myeloid leukaemia 2. Life expectancy of at least 8 weeks 3. Karnofsky / Lansky scale score of > or = to 50% 4. Biochemical indices within ranges as specified in the protocol 5. Aged > 6 months to <19 years 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Chronic myeloid leukaemia 2. Cytotoxics, vincristine, anti-neoplastics within two weeks. One week for investigational medicinal products (except antibodies, for which a four week window must be observed), one week for protein kinase inhibitors and Intrathecal therapy before treatment 3. Central nervous system (CNS) disease 4. Ongoing toxic manifestations of previous treatments 5. Prior exposure to an aurora kinase inhibitor 6. Pregnant or lactating women 7. Fractional shortening of =29% on Echocardiogram 8. Previous anthracycline treatment with a cumulative dose equal to or greater than 450mg/m2 doxorubicin equivalent 9. Uncontrolled arterial hypertension defined as a systolic and / or diastolic blood pressure greater than or equal to the 95th percentile for age and height 10. Congenital heart disease, with the exception of patent foramen ovale or small muscular ventricular septal deficit (within the first year of life) 11. Active graft vs. host disease 12. Patients experiencing significant toxicity following Haematopoietic Stem Cell Transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of a dose of AT9283 for Phase II evaluation at end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessing AT9283 target kinase inhibition through pharmacodynamic analysis at end of study 2. Determining safety and tolerability of AT9283 throughout study conduct 3. Documenting evidence of activity of AT9283 by disease response assessment throughout study conduct 4. Identifying predictive molecular markers through pharmacodynamic analysis at end of study 5. Investigating the PK profile of AT9283 in paediatric patients at end of study | — |
Countries
England, United Kingdom
Outcome results
None listed