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Contact Information:

Dr Lynley Marshall
LynleyVanessa.Marshall@icr.ac.uk


Esmart Team
esmart@trials.bham.ac.uk


Study Location:

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Be Part of Research - Trial Details - ESMART

ESMART

Recruiting

Open to: Female / Male

Age: 0 Years - N/A

1.0 Mile Away

Medical Conditions

Malignant neoplasms of ill-defined, secondary and unspecified sites
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Despite the good overall survival in children and adolescents with cancer, outcomes remain poor for high risk groups and those that do not respond to frontline therapies. Better treatment options which work in novel ways are required. A number of drugs that target the specific underlying pathways which allow individual cancers to grow have been developed in adult oncology and have potential to be effective in paediatric tumours. ESMART is a European trial which will offer children and adolescents with different types of relapsed or refractory cancer who have exhausted standard treatment access to several new drugs/drug combinations as part of a single umbrella study with multiple arms. A unique feature of entry to the trial is the requirement for results from extensive molecular analysis from a biopsy at the time of relpase (biopsy and analysis not part of ESMART) so that the treatment arm offered is the ‘best fit’ in targeting the biology of each patient’s cancer. This will be the first study in the UK to routinely offer this advanced tumour profiling in children and adolescents. The hope is that this approach will increase the chances of the drug working and expand our knowledge of what molecular and genetic features predict therapeutic response. The trial aims to first identify the safety and correct dose of these treatments in children using knowledge from adult trials and where there seems to be evidence of anti-tumour activity to enrol more patients to assess if these drugs are effective. An efficient study design has been adopted to accelerate these drug development objectives and with the option to add treatment arms as new drugs become available. The following drugs are currently being tested in this trial: Ribocliclib, Topotecan, Temozolomide, AZD1775, Carboplatin, Olaparib, Irinotecan, Nivolumab, Enasidenib, Lirilumab.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

20 Dec 2019 28 Apr 2024

Interventional

Interventional type: Drug;Radiotherapy;Immunotherapy;



You can take part if:



You may not be able to take part if:


Exclusion criteria: 1. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease. Patients on stable doses of corticosteroids for at least 7 days prior to receiving study drug may be included. 2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome). 3. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality) unstable ischemia, congestive heart failure, within 12 months of screening). 4. Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection. 5. Presence of any > = CTCAE grade 2 treatment-related toxicity with the exception of alopecia, ototoxicity or peripheral neuropathy. 6. Systemic anticancer therapy within 21 days of the first study dose or 5 times its half-life, whichever is less. 7. Previous myeloablative therapy with autologous haematopoietic stem cell rescue within 8 weeks of the first study drug dose 8. Allogeneic stem cell transplant within 3 months prior to the first study drug dose. Patients receiving any agent to treat or prevent graft-versus host disease (GVHD) post bone marrow transplant are not eligible for this trial. 9. Radiotherapy (non-palliative) within 21 days prior to the first dose of drug (or within 6 weeks for therapeutic doses of MIBG or craniospinal irradiation). 10. Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumour biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of the investigational drug is administered. 11. Currently taking medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes (Refer to Appendix 8). 12. Currently taking medications that are mainly metabolized by CYP3A4/5, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or the drug transporters Pgp (MDR1), BCRP, OATP1B1, OATP1B3, OCT1 and OCT2 and have a low therapeutic index that cannot be discontinued at least 7 days or 5 x reported elimination halflife prior to start of treatment with any of the investigational drugs and for the duration of the study (Refer to Appendix 9). 13. Known hypersensitivity to any study drug or component of the formulation. 14. Pregnant or nursing (lactating) females. 15. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Victoria Infirmary
    Queen Victoria Road
    Newcastle Upon Tyne
    Tyne And Wear
    NE1 4LP
  • The Royal Marsden Hospital (surrey)
    Downs Road
    Sutton
    Surrey
    SM2 5PT
  • Birmingham Children's Hospital
    Steelhouse Lane
    Birmingham
    West Midlands
    B4 6NH


The study is sponsored by INSTITUT GUSTAVE ROUSSY (France) and funded by Cancer Research UK .




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for Trial ID: CPMS 41564

Last updated 12 September 2023

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