TALENT (GETNE1509) V.3.0 05/nov/2015

• Research type

  Research Study

• Full title

  Trial to Assess the efficacy of LEnvatinib in metastatic Neuroendocrine Tumors (TALENT Study)

• IRAS ID

  188636

• Contact name

  Juan Valle

• Contact email

  Juan.Valle@christie.nhs.uk

• Sponsor organisation

  GETNE (Grupo Español de Tumores Neuroendocrinos)

• Eudract number

  2015-001467-39

• Clinicaltrials.gov Identifier

  REec-2015-1694, Spanish Clinical Trial Registry (REEC)

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  This is a study looking at how effective a new treatment, called lenvatinib, is in patients with neuroendocrine tumours (NETs) which is advanced: either inoperable or metastatic (when disease has spread to other organs). Lenvatinib is a treatment that is already licensed for thyroid cancer and has its effects by blocking the development of new blood vessels that encourage cancers to grow; it is being tested in other cancers, such as in this study. The effect of lenvatinib in this study will be assessed by CT scans in terms of response (tumour shrinkage); how long control is achieved for as well as any side-effects that develop. Patients with NETs arising in the pancreas or the gastrointestinal (digestive) system will be recruited and will be analyzed separately. All consenting patients will receive lenvatinib (this is an open-label study with no use of placebo).
  The study will be performed in about 15 investigation sites in Europe which will include approximately 110 patients with neuroendocrine tumours. The estimated duration of the study is of 36 months. The results of this study will be known approximately 24 months after the last subject's enrollment

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  16/NW/0200

• Date of REC Opinion

  9 May 2016

• REC opinion

  Further Information Favourable Opinion