A Cancer Research UK Phase I trial of AT9283 (a selective inhibitor of aurora kinases) given over 72 hours every 21 days via intravenous infusion in children and adolescents aged 6 months to 18 years with relapsed and refractory acute leukaemia

Cancer Research UK0 个研究点目标入组 7 人开始时间: 2011年10月31日最近更新: 2022年11月7日

适应症

试验速览

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•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.

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