AT9283 in children and adolescents with acute leukaemia

ISRCTN	ISRCTN97388141
DOI	https://doi.org/10.1186/ISRCTN97388141
ClinicalTrials.gov (NCT)	NCT01431664
Clinical Trials Information System (CTIS)	2009-016952-36
Protocol serial number	11214
Sponsor	Cancer Research UK
Funder	Cancer Research (UK)

Submission date: 31/10/2011
Registration date: 31/10/2011
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-at9283-for-children-and-young-people-with-acute-leukaemia

Contact information

Mr Philip Ross
Scientific

Cancer Research UK
Drug Development Office
Angel Building
407 St. John Street
London
EC1V 4AD
United Kingdom

Phone	+44 20 7242 0200
Email	Philip.Ross@cancer.org.uk

Study information

Primary study design	Interventional
Study design	Non-randomised interventional treatment
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	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
Study objectives	An open label, multi-centre, phase I dose escalation study of the aurora kinase inhibitor AT9283 in paediatric patients with relapsed and refractory acute leukaemia.
Ethics approval(s)	East Midlands - Derby Medical Research Ethics Committee, 08/11/2010, ref: 10/H0405/75
Health condition(s) or problem(s) studied	Acute Leukaemia
Intervention	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 defined in the protocol; Treatment with AT9283, 72 hour infusion every 21 days.
Intervention type	Other
Primary outcome measure(s)	Identification of a dose of AT9283 for Phase II evaluation at end of study
Key secondary outcome measure(s)	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
Completion date	01/10/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	19 Years
Sex	All
Target sample size at registration	15
Total final enrolment	7
Key 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
Key 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.
Date of first enrolment	14/09/2011
Date of final enrolment	01/10/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Cancer Research UK

London
EC1V 4AD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link added.
16/04/2019: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific)
2. The total final enrolment was added
18/11/2016: No publications found in PubMed, verifying study status with principal investigator.