AT9283 in children and adolescents with acute leukaemia
| ISRCTN | ISRCTN97388141 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97388141 |
| EudraCT/CTIS number | 2009-016952-36 |
| ClinicalTrials.gov number | NCT01431664 |
| Secondary identifying numbers | 11214 |
- 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
Contact information
Mr Philip Ross
Scientific
Scientific
Cancer Research UK
Drug Development Office
Angel Building
407 St. John Street
London
EC1V 4AD
United Kingdom
| Phone | +44 20 7242 0200 |
|---|---|
| Philip.Ross@cancer.org.uk |
Study information
| Study design | Non-randomised interventional treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 14/09/2011 |
| Completion date | 01/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 15; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Cancer Research UK
London
EC1V 4AD
United Kingdom
EC1V 4AD
United Kingdom
Sponsor information
Cancer Research UK
Charity
Charity
Drug Development Office
Angel Building
407 St. John Street
London
EC1V 4AD
United Kingdom
| Website | http://www.cancerresearchuk.org/ |
|---|---|
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | |||
| Plain English results | 26/10/2022 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
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.
