MTL-005 Radiosensitization in patients with head & neck cancer

• Research type

  Research Study

• Full title

  An open phase 1 exploratory study of MTL-005 radiosensitization in Patients with advanced carcinoma of the head and neck. Part 1 to evaluate safety in a dose escalation design in patients indicated for palliative radiotherapy. Part 2 to evaluate safety and efficacy in a dose escalation design in patients indicated for cisplatin chemoradiotherapy.

• IRAS ID

  102641

• Contact name

  Stefano Schipani

• Sponsor organisation

  MorEx Development LLP

• Eudract number

  2012-000668-61

• ISRCTN Number

  n/a

• Research summary

  This is an open-label, phase I exploratory study of MTL-005 Radiosensitization in patients with advanced carcinoma of the head and neck. This study will evaluate safety and efficacy in a dose escalation design. This study consists of two parts: Part 1: To evaluate the safety and tolerability of MTL-005 in patients indicated for palliative radiotherapy. Up to 12 patients will be enrolled. Part 2: To evaluate the safety and efficacy of MTL-005 in patients indicated for Cisplatin chemoradiotherapy. Up to 18 patients will be enrolled.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0498

• Date of REC Opinion

  21 Jan 2013

• REC opinion

  Further Information Favourable Opinion