CHARIOT
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
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, 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 & 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