A study of Berzosertib for cancer of the food pipe (oesophagus) and other solid tumours (CHARIOT)

Cancer type:

All cancer types
Oesophageal cancer

Status:

Results

Phase:

Phase 1

This study looked at Berzosertib (M6620) with:

  • radiotherapy for oesophageal cancer
  • chemotherapy for other solid tumours

A solid tumour is any cancer apart from blood cancers such as leukaemia, lymphoma or myeloma.

The study was supported by Cancer Research UK. It was open for people to join between 2018 and 2021. The team analysed the results in 2022.

More about this trial

Doctors sometimes treat oesophageal cancer with surgery. For people who can’t have or don’t want surgery, they use:

  • chemotherapy
  • radiotherapy 
  • a combination of chemotherapy and radiotherapy (chemoradiation)

Berzosertib is a targeted cancer drug. It works by blocking signals that tell damaged cancer cells to repair themselves. 
 
Researchers wanted to find out if it would be useful to have Berzosertib alongside chemotherapy or radiotherapy. 

The main aims of this study were to find out:

  • the best dose of Berzosertib to give in combination with either chemotherapy or radiotherapy
  • what the side effects are

Summary of results

This was a phase 1 study. Everyone taking part had Berzosertib. Some people had it with their radiotherapy. Others had it with their chemotherapy.

The people taking part had different doses of Berzosertib. The first few people who took part had a lower dose. As they didn’t have any serious side effects, other people had a higher dose. This is called a dose escalation study.

Some people had one treatment a week. Other people had a higher total dose of Berzosertib each week, but it was split into 2 treatments. This was so the research team could find out the best way to give treatment.

There were 3 parts to this study. The results for Stage A1 and Stage A2 are below. The research team weren’t able to run Stage B as there was no funding available.

Results from Stage A1
Stage A1 looked at Berzosertib and radiotherapy for people with oesophageal cancer. 

There were 16 people in this part of the study. They had radiotherapy every day, Monday to Friday, for 3 weeks. They had Berzosertib once or twice a week for 3 weeks.

The results showed that this combination of treatment didn’t cause any severe side effects. Five people taking part had moderate side effects. The most common was a rash.

The research team decided the highest dose in Stage A1 was the best dose to use with radiotherapy.

Results from Stage A2
Stage A2 looked at Berzosertib and chemotherapy for people with any solid tumour Open a glossary item

There were 18 people in this part of the study. They had cisplatin once every 3 weeks, for up to 18 weeks. And they took capecitabine tablets every day during this time. These are both types of chemotherapy. They also had Berzosertib once or twice a week for up to 18 weeks.

The results showed that this combination of treatment didn’t cause too many side effects. The most common side effects were a drop in white blood cells Open a glossary item and blood clotting cells (platelets).

The research team found that the second highest dose in Stage A2 was the best one to use with chemotherapy.

Conclusion
The study team concluded that Berzosertib with chemotherapy or radiotherapy didn’t cause too many side effects. They also found the best dose to use. 

They suggest more trials are done to find out how well it works.

Where this information comes from    
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently peer reviewed Open a glossary item or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.
 

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Maria Hawkins

Supported by

Cancer Research UK
Merck KGaA
University of Oxford
Oncology Clinical Trials Office (OCTO), University of Oxford
CRUK/MRC Oxford Institute for Radiation Oncology
Experimental Cancer Medicine Centre (ECMC)

Other information

This is Cancer Research UK trial number CRUKD/15/011.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14312

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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