NUC-1031 in patients with solid tumours

• Research type

  Research Study

• Full title

  A two-part, phase I open label, dose-escalation study to assess the safety, pharmacokinetics and activity of NUC-1031, a nucleoside analogue, in patients with advanced solid tumours

• IRAS ID

  75723

• Contact name

  Sarah Blagden

• Sponsor organisation

  Imperial College London

• Eudract number

  2011-005232-26

• ISRCTN Number

  not issued

• Research summary

  This is a two-part Phase I, open label, dose-escalation, study of NUC-1031 as a single agent in patients with advanced solid tumours who have failed to respond to or who have relapsed after treatment with standard therapy. NUC-1031 is a ProTide of gemcitabine, a drug that has been used widely and effectively against cancers for many years. Both NUC-1031 and gemcitabine work by preventing cancer cells from dividing by attacking their DNA (deoxyribonucleic acid). Non clinical studies have shown that NUC-1031 is more effective than gemcitabine because it is able to reach cancer cells by passive diffusion, is less easily degraded by the cancer cell, and delivers the monophosphate form of the active agent. The first part of the study is to determine recommended phase 2 dose by dose escalation and the second part is to explore preliminary anti-tumour activity.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  12/LO/1100

• Date of REC Opinion

  3 Sep 2012

• REC opinion

  Further Information Favourable Opinion