Condition category
Cancer
Date applied
31/10/2011
Date assigned
31/10/2011
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Philip Ross

ORCID ID

Contact details

Cancer Research UK
Drug Development Office
Angel Building
407 St. John Street
London
EC1V 4AD
United Kingdom
+44 20 7242 0200
Philip.Ross@cancer.org.uk

Additional identifiers

EudraCT number

2009-016952-36

ClinicalTrials.gov number

NCT01431664

Protocol/serial number

11214

Study information

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

Acronym

Study hypothesis

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

East Midlands - Derby Medical Research Ethics Committee, 08/11/2010, ref: 10/H0405/75

Study design

Non-randomised interventional treatment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase I

Drug names

Primary outcome measures

Identification of a dose of AT9283 for Phase II evaluation at end of study

Secondary outcome measures

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

Overall trial start date

14/09/2011

Overall trial end date

01/10/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 15; UK Sample Size: 15

Participant 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.

Recruitment start date

14/09/2011

Recruitment end date

01/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK
London
EC1V 4AD
United Kingdom

Sponsor information

Organisation

Cancer Research UK

Sponsor details

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

Sponsor type

Charity

Website

http://www.cancerresearchuk.org/

Funders

Funder type

Charity

Funder name

Cancer Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/11/2016: No publications found in PubMed, verifying study status with principal investigator.