Leukemia Clinical Trial
Official title:
A Cancer Research UK Phase I/IIa 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 Leukemia
RATIONALE: AT9283 may stop the growth of cancer cells by blocking some of the enzymes needed
for cell growth.
PURPOSE: This phase I/IIa clinical trial is studying the side effects and best dose of
AT9283 in treating young patients with relapsed or refractory acute leukemia.
OBJECTIVES:
Primary
- To identify the maximum-tolerated dose and recommended phase IIb dose of multikinase
inhibitor AT9283 in pediatric patients with relapsed or refractory acute leukemia.
Secondary
- To evaluate the safety and tolerability of this drug in these patients.
- To document evidence of efficacy of this drug in these patients.
- To investigate the pharmacokinetic profile of this drug in plasma in these patients.
Tertiary
- To assess target kinase inhibition by multikinase inhibitor AT9283 in these patients.
- To identify potential predictive molecular biomarkers in these patients.
OUTLINE: This is a multicenter study.
Patients receive multikinase inhibitor AT9283 IV continuously over 72 hours. Treatment
repeats every 21 days* for 6 courses in the absence of disease progression or unacceptable
toxicity. Patients achieving benefit of treatment may continue for up to 6 more courses at
the discretion of the chief/principal investigator.
NOTE: *Course length may be extended to a maximum 42 days to allow for recovery of blood
counts. Intrathecal therapy is permitted from course 2 onwards in patients with ALL.
Blood specimens are collected for pharmacokinetic and pharmacodynamic studies including
molecular predictive biomarkers and ex vivo and in vivo measurement of kinase inhibition
assessments.
After completion of study treatment, patients are followed up for 42 days or until recovery
of blood counts (whichever is the sooner).
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
;
Masking: Open Label, Primary Purpose: Treatment
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