A trial of vistusertib with paclitaxel for solid tumours (TAX-TORC)

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Cancer type:

All cancer types

Status:

Results

Phase:

Phase 1

This trial looked at vistusertib and paclitaxel for people with solid tumours including ovarian cancer and non small cell lung cancer. A solid tumour is any type of cancer apart from leukaemia or lymphoma. 

This trial was supported by Cancer Research UK.

More about this trial

Vistusertib (AZD2014) is a type of targeted cancer treatment called an mTOR inhibitor. It stops signals that cancer cells use to divide and grow.
 
In this trial, researchers looked at vistusertib alongside a chemotherapy drug called paclitaxel.
 
The main aims of the trial were to:
  • find the best dose of vistusertib to have with paclitaxel
  • learn more about the side effects
  • see what happens to the vistusertib in the body

Summary of results

The research team found the best dose to give and concluded that vistusertib and paclitaxel could be a useful treatment.
 
This trial was open for people to join between 2013 and 2016. The research team reported the results in 2018.
 
About the trial
To begin with they recruited 22 people with advanced cancer. Everyone had paclitaxel through a drip into a vein once a week. They had vistusertib tablets for either 2 days or 3 days each week, for 6 weeks out of 7. Each 7 week period is one cycle of treatment.
 
Results
The first few people who took part had the lowest dose of vistusertib. As they didn’t have any serious side effects, the next few people had a higher dose. And so on, until they found the best dose to give. This is called a phase 1 dose escalation study.
 
The most common side effects for people who had vistusertib 3 times a week were extreme tiredness (fatigue), a drop in red blood cells and diarrhoea. 
 
The most common side effects for people who had vistusertib twice a week were feeling sick, fatigue and tingling in hands and feet (peripheral neuropathy).
 
The research team decided it would be best to use a lower dose for both groups.
 
People who took part after this all had same dose of vistusertib. This is called the dose expansion phase of the trial. Of the people who had treatment:
Ovarian cancer
The research team were able to assess how well treatment had worked for 21 people who had ovarian cancer. They found that it went away in 1 person and got smaller in 11 people. This means that 12 people’s cancer (57%) responded to treatment. 
 
It was just over 6 months before the cancer started to grow again. 
 
They also measured a protein called CA125 in blood samples. A drop in the level of CA125 can mean that the cancer is responding to treatment. They found that CA125 was lower after treatment in 15 out of 21 people (71%).
 
It is difficult to draw any firm conclusions from a small trial. But these results are promising compared to other trials which have looked at paclitaxel alone and some other treatments.
 
Lung cancer
Some of the first few people who took part had some severe side effects, including fatigue and diarrhoea. And more people than expected had a lung infection. The research team reviewed the information and decided the remaining people taking part should have a lower dose of vistusertib. 
 
The research team were able to assess how well treatment had worked for 29 people who had lung cancer. The cancer:
  • went away in 1 person and got smaller in 1 person out of 11 people who had the higher dose (18%)
  • didn’t go away in anyone but got smaller in 7 out of 18 people who had the lower does (39%)
It was just under 5 months before the cancer started to grow again. 
 
These results are better than for some other treatments for lung cancer.
 
Conclusion
The research team concluded that, at the right dose, the combination of paclitaxel and vistusertib didn’t cause too many side effects. And that it could be a useful treatment in the future. They suggest it is looked at in further trials to find out more about how well it works.
 
Where this information comes from
We have based this summary on information from the research team. Some of the information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. Some of the information we quote is from the published paper, and some is from additional information which has not been published. 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

Dr Udai Banerji

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUKDE/12/013.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10380

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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