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M6620 plus standard treatment in oesophageal and other cancer

CHARIOT trial logo

 

 

 

 

Full title

A phase I dose escalation safety study combining the ATR inhibitor M6620 with chemoradiotherapy in oesophageal cancer & other solid cancers using time to event continual reassessment method

Chief Investigator: Maria Hawkins

Sponsor: University of Oxford                                           

EudraCT Number: 2015-003965-27            

Study Design & Population

CHARIOT is an interventional, phase I, open label, multicentre, schedule finding trial using time to event continual reassessment method (TiTE-CRM). This study will test the combination of a novel ATR inhibitor with radiotherapy or chemoradiotherapy in oesophageal cancer and other solid cancers in palliative treatment.

Stage A1: M6620 + radiotherapy in the palliative treatment for oesophageal cancer. Target recruitment; up to 20 participants.

Stage A2: M6620 + chemotherapy (cisplatin/capecitabine) in the palliative treatment for solid cancer. Target recruitment; up to 20 participants.

Stage A1 & A2 run parallel to one another

STUDY STATUS

In Close Out

 

Sites open to recruitment:

  • Churchill Hospital, Oxford
  • Beatson Hospital, Glasgow
  • Christie Hospital, Manchester
  • Velindre Cancer Centre, Cardiff
  • St James University Hospital, Leeds

Study Schema (Click to enlarge)

 CHARIOT Schema A1

CHARIOT Schema A2

 

Objectives

Stage A1             

Primary

  • To determine the best tolerated M6620 treatment schedule administered concomitantly with radiotherapy (RT) only in the palliative treatment of oesophageal cancer

Secondary

  • To determine the safety and toxicity profile of M6620 administered concomitantly with RT only in the palliative treatment of oesophageal cancer
  • To determine if M6620 can be delivered in combination with palliative RT
  • Efficacy of the combination        

Stage A2                             

Primary

  • To determine the best tolerated M6620 treatment administered concomitantly with chemotherapy (Cisplatin and Capecitabine) only in the palliative treatment of solid cancer              

Secondary

  • To determine the safety and toxicity profile of M6620 administered concomitantly with chemotherapy (Cisplatin and Capecitabine) only in the palliative treatment of solid cancer
  • To determine if M6620 can be delivered in combination with palliative chemotherapy
  • Efficacy of the combination        

Data Submission

Data submission for this trial is via electronic submission of data in OpenClinica

 

Funding & Acknowledgements

CHARIOT is sponsored by the University of Oxford and funded by CRUK (C43735/A20874) and Merck KGaA. Statistical support is provided by the Centre for Statistics in Medicine (CSM).

Contact Us

Oncology Clinical Trials Office (OCTO)

General enquiries: 01865 617 084

Email: octo-chariot@oncology.ox.ac.uk

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