A study looking at a drug called E7449 in people with advanced solid tumours, or advanced B cell cancers

Cancer type:

Adrenal gland cancer
Biliary tree cancers
Bowel (colorectal) cancer
Breast cancer
Gallbladder cancer
Kidney cancer
Leukaemia
Lung cancer
Lymphoma
Pancreatic cancer
Secondary cancers
Skin cancer
Small bowel cancer

Status:

Results

Phase:

Phase 1

This study learnt more about a drug called E7449 for solid tumours Open a glossary item and cancers affecting immune system Open a glossary item cells called B cells. It was for people with cancer that had spread or came back after treatment.

E7449 is a type of targeted drug Open a glossary item that blocks a protein called PARP (a PARP inhibitor Open a glossary item). PARP repairs damage to DNA Open a glossary item in our cells. Blocking PARP may stop cancer cells being able to repair themselves.

The main aims of the study were to:

  • find the best dose of E7449 
  • see how well this dose works in people with advanced cancer

The trial was open for people to join between 2012 and 2015. The team published the results in 2020.

Summary of results

This study found the best dose of E7449 to give. 

Results

This was a phase 1 Open a glossary item study. 41 people with an advanced solid tumour took part. No one with a B cell cancer took part in the study. 

E7449 is a tablet. It is taken once a day. 

The first few people had a small dose of E7449. The next few had a higher dose and so on. The study team monitored people carefully to check for side effects. The best dose was the highest dose that did not cause too many side effects or too severe side effects. The team found that the best dose to give is 600mg.  

The team looked at how well E7449 worked. They found that of the 41 people:

  • the cancer had shrunk in 2 people 
  • the cancer stayed the same in 13 people

The team looked at tissue samples (biopsies Open a glossary item) taken when the people were diagnosed. They wanted to know if a substance (biomarker Open a glossary item) called 2X-121 DPR could show whether E7449 might work for people and how well it might work. They found that in 13 people 2X-121 DPR did predict how well E7449 worked. 

Side effects
The most common side effects of E7449 were:

  • tiredness (fatigue)
  • red colouring of the urine 
  • feeling or being sick
  • diarrhoea or constipation
  • skin reactions such as a rash, colour changes, itching and dry skin 
  • loss of appetite
  • depression
  • increased sensitivity to light 
  • swelling around the eyes

Conclusion
The team concluded that:

  • 600mg of E7449 is the best dose to give in future trials
  • E7449 could help people with an advanced cancer
  • the biomarker 2X-121 DPR can help to predict which people it might work best for

They said that further research should be done using E7449 and the biomarker 2x-121 DRP. They reported that there are 2 trials underway in Europe looking at this.  

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

First-in-human study of the PARP/tankyrase inhibitor E7449 in patients with advanced solid tumours and evaluation of a novel drug-response predictor 

R Plummer and others
British Journal of Cancer 2020. Volume 123, Issue 4, Pages 525 to 533.

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.
 

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 Ruth Plummer

Supported by

Eisai
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9646

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

Last reviewed:

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