A trial looking at vistusertib and selumetinib for advanced cancer (TORCMEK)

Cancer type:

All cancer types

Breast cancer

Secondary cancers

Status:

Results

Phase:

Phase 1/2

This trial looked at vistusertib and selumetinib for solid tumours Open a glossary item that had spread into the surrounding tissues or elsewhere in the body. Cancer that has spread is advanced cancer .

The trial was for people who didn’t have any standard treatment Open a glossary item options available to them.

It was open for people to join between 2015 and 2018. The team published some results in 2017 and reported some more results in 2022. Cancer Research UK supported this trial.

You pronounce selumetinib as sell-you-me-ti-nib.

More about this trial

Vistusertib (AZD2014) and selumetinib are both types of targeted cancer drugs Open a glossary item called cancer growth blockers. They block signals that cancer cells use to divide and grow.

Both drugs had been looked at in trials as a treatment on their own, or with other drugs. Early research showed that the combination of vistusertib and selumetinib worked better than either drug on its own. So researchers were doing this trial to find out more. This was the first time people had both drugs together.

There were 2 parts to this trial. The first part was for people with any type of cancer. The second part was for people with certain cancers including non small cell lung cancer and triple negative breast cancer.

Vistusertib and selumetinib are tablets. Everyone had treatment for as long as it was working and the side effects weren’t too bad.

The main aims of this phase 1/2 trial were to find out:

how safe treatment is
the best dose of vistusertib and selumetinib to give
the best schedule of treatment
what the side effects are

Summary of results

61 people took part in total:

25 joined part one
36 joined part two

The team had hoped to find more people but the trial closed earlier than planned. This was because the company making vistusertib decided to stop researching it.

Results for part one (dose escalation)
The first few people had the lowest dose of vistusertib and selumetinib. The next few people had a higher dose if they didn’t have any serious side effects. And so on, until the doctors found the best dose of each drug to give. This is called a dose escalation study. The team also looked at the best schedule to have.

The team found the best dose and schedule for vistusertib and selumetinib.

Results for part two (dose expansion)
The team had the results for 25 people in part 2. They all had the best dose and schedule for both drugs that was found in part 1.

The trial team looked at whose cancer went away completely, went away a little bit or stayed the same for at least 12 weeks. This was the main aim of the trial. This happened in:

no one out of the 4 people who had triple negative breast cancer
3 out of 5 people who had squamous cell non small cell lung cancer
3 out of 10 people who had other types of non small cell lung cancer
1 out of 6 people who had another type of solid cancer

These results showed that treatment seemed to work for a few people. But the team say it’s difficult to draw any firm conclusions with such a small number of people in the trial.

Side effects
Everyone had at least one side effect. Some of these were mild or didn’t last long.

Some people had more severe side effects. This happened in:

14 out of 25 people (56%) in group 1
25 out of 36 people (69%) in group 2

The most common severe side effects included:

skin rash
diarrhoea
sore mouth
liver changes
tiredness (fatigue)

Conclusion
The trial team found the best dose and schedule for vistusertib and selumetinib. They say it was hard to draw any firm conclusions about how well the treatment worked. This was because of the small number of people who took part.

All trials add to our knowledge and understanding of cancer and how to treat it.

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.

A study of vistusertib in combination with selumetinib in patients with advanced cancers: TORCMEK phase Ib results.
P Schmid and others
Journal of Clinical Oncology, 2017. Volume 35, Issue 15, supplement.

Where this information comes from
We have based this summary on the information in the article above. Some of the information has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. Some of the information may not have been. 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.