A trial looking at Z-360 and gemcitabine for advanced pancreatic cancer that can't be removed with an operation

Cancer type:

Pancreatic cancer

Status:

Results

Phase:

Phase 2

This trial was looking into a new type of hormone therapy, along with chemotherapy, for cancer of the pancreas.

Doctors often treat pancreatic cancer with surgery, if possible. Or treat with a chemotherapy drug called gemcitabine (Gemzar). But for some people the cancer may start to grow again or come back. If this happens the cancer is more difficult to treat.

Gastrin is a hormone Open a glossary item that normally stimulates the release of acid into your stomach. This acid helps with digestion. Gastrin also stimulates the growth of certain cells that protect the stomach from digestive acid. Some studies show that gastrin is involved in making pancreatic cancer cells grow.

Z-360 is a new type of hormone therapy Open a glossary item. It is called a ‘gastrin receptor antagonist’. This means that it blocks the action of gastrin. Doctors hoped that taking Z-360 would help reduce the amount of digestive acid produced by the stomach, and help to slow the growth of the cancer.

Doctors hoped that taking Z-360 in combination with gemcitabine would work better than gemcitabine alone. But Z-360 is a new drug and doctors didn’t know how well it would work.

The aims of this trial were to find out

  • What the side effects of Z-360 were
  • How well the combination of Z-360 and gemcitabine worked for pancreatic cancer

Summary of results

The research team found that it was safe to give the combination of Z-360 and gemcitabine to people with advanced pancreatic cancer.

This trial recruited 33 people. They were put into 1 of 3 treatment groups

  • 12 had gemcitabine and a dummy drug (placebo Open a glossary item)
  • 9 had gemcitabine and a low dose of Z-360
  • 12 had gemcitabine and a high dose of Z-360

Of the 33 people recruited to take part in the trial, all had at least 1 treatment as a part of the trial. The most common side effects reported were diarrhoea and feeling sick (nausea).

In 26 of these people, the researchers were able to assess the effect the treatment had on their cancer.

Of the 10 people who had gemcitabine and the dummy drug (placebo), the cancer

  • Stayed the same in 6 people – this is called stable disease Open a glossary item
  • Continued to grow in 4 people

Of the 8 people who had the low dose of Z-360 and gemcitabine, the cancer

  • Stayed the same in 5 people
  • Continued to grow in 3 people

Of the 8 people who had the high dose of Z-360 and gemcitabine, the cancer

  • Stayed the same in 2 people
  • Continued to grow in 6 people

The people who had Z-360 and gemcitabine reported better pain control and improved quality of life than those who had the dummy drug and gemcitabine.

Although the numbers were small the researchers thought that the results showed Z-360 was safe and well tolerated when given with gemcitabine to people with advanced pancreatic cancer. But these results need to be confirmed by studying this combination further in a phase 3 trial with a bigger number of people.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial 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

Prof Tim Meyer

Supported by

Experimental Cancer Medicine Centre (ECMC)
Zeria Pharmaceutical

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 769

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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