Title

CHARIOT

Chief Investigator: 

M6620 plus standard treatment in oesophageal and other cancer

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

Sponsor: University of Oxford                                           EudraCT Number: 2015-003965-27            

 

STUDY DESIGN & POPULATION

CHARIOT is an interventional, phase I, open label, multicentre, 3-stage, 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 both palliative and definitive treatment.

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

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

Stage A1 & A2 run parallel to one another

Stage B: M6620 in combination with cisplatin/capecitabine and radical radiotherapy in patients with oesophageal tumours for radical chemoradiotherapy. Stage B will commence once sufficient data is collected from stages A1 and A2. Target 25 participants.

STUDY STATUS

Sites open to recruitment:

  • Churchill Hospital, Oxford

Sites in set-up:

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

 

STUDY SCHEMA

 

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        

Tertiary

  • To evaluate pharmacokinetics (PK) of M6620

Stage B

Primary

  • To determine the best tolerated M6620 treatment schedule administered concomitantly with radiotherapy (dCRT) in combination with cisplatin and capecitabine in the radical treatment of oesophageal cancer     

Secondary

  • To determine the safety and toxicity profile of M6620 administered concomitantly with dCRT in combination with cisplatin and capecitabine in the radical treatment of oesophageal cancer
  • To determine tolerance and ability to deliver M6620 in combination with standard dCRT
  • Efficacy and long term safety of the combination              

Tertiary

  • To explore target effects in tissue            

 

DATA SUBMISSION

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

 

FUNDING & ACKNOWLEGDEMENTS

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).

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