A trial looking at olaparib for people with advanced solid tumours

Cancer type:

All cancer types
Secondary cancers

Status:

Open

Phase:

Phase 2

This trial is for people who have had treatment for a solid tumour that has spread to other parts of the body (advanced cancer). A solid tumour is any type of cancer apart from blood or lymphatic cancers such as leukaemia Open a glossary item or lymphoma Open a glossary item.

It is for people who have changes (mutations Open a glossary item) in the homologous recombination repair genes. The homologous recombination repair genes make proteins that help cells to repair themselves.

More about this trial

Cancer cells have changes in their genes that make them different from normal cells. So a common treatment for advanced cancers are drugs that work by targeting those differences. These are called targeted drugs.

Olaparib (Lynparza) is a type of targeted drug called a cancer growth blocker. It works by blocking the protein that helps cells to repair themselves. When cancer cells can no longer repair themselves, they die. Olaparib is already a possible treatment for some types of ovarian cancer that has come back after treatment.

Everyone taking part in this trial has olaparib for as long as it is helping them, and the side effects aren’t too bad.  

The main aims of this trial are to:

  • find out how well olaparib works for advanced cancers
  • learn more about the side effects of olaparib

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this trial if all of the following apply:

  • you have a solid tumour (not a leukaemia or lymphoma) that has spread to other parts of the body (advanced)
  • your doctor thinks that you can’t have treatment to try to cure your cancer
  • you have satisfactory blood tests results  
  • you have changes (mutations) in the homologous recombination repair genes. Your doctor can tell you more about this
  • you have at least one area of cancer that can be seen and measured on a scan
  • you are willing to have a sample of tissue taken (biopsy) if there isn’t a suitable sample available
  • you can swallow and absorb tablets
  • you can do everything apart from heavy physical work (performance status 0 or 1)
  • you are at least 18 years old 
  • you are willing to use reliable contraception during treatment and for up to 3 months afterwards if there is any possibility that you or your partner could become pregnant

Who can’t take part

Cancer related

You cannot join this trial if any of these apply:

  • you have breast or ovarian cancer that has changes (mutations) in the BRCA gene
  • your advanced cancer got worse (progressed) after treatment with a platinum chemotherapy drug such as cisplatin or carboplatin
  • you have had olaparib or any other similar drug
  • you have another cancer that is getting worse or that needed treatment in the past 5 years, apart from non melanoma skin cancer Open a glossary item or carcinoma in situ Open a glossary item  of the cervix or breast that has been successfully treated
  • you have a blood disorder called myelodysplasia syndrome (MSD) or acute myeloid leukaemia (AML)
  • you have moderate or severe side effects from previous cancer treatment apart from hair loss
  • your cancer has spread to the brain unless you have had treatment, it has been stable for at least 4 weeks and you haven’t had steroids in the last 2 weeks
  • your cancer has spread to the spinal cord or the layers of tissue that surround the brain (carcinomatous meningitis)

Medical conditions

You cannot join this trial if any of these apply. You:

  • are taking part, or have taken part in another trial looking at a new drug or device in the last month
  • have an active infection
  • have had drugs that stimulate your body to make white blood cells Open a glossary item such as G-CSF in the last month
  • have had a major surgery in the last 2 weeks and you still have side effects from it
  • have heart problems such as an irregular heart rhythm (arrhythmia) or you have had a heart attack in the last 3 months
  • have lung problems such as fibroses  Open a glossary item and pneumonitis  Open a glossary item
  • have a problem with your digestive system Open a glossary item 
  • have fits (seizures) that aren’t controlled
  • take, or have taken drugs that affect a group of enzymes called cytochrome P. Your doctor can tell you more about this
  • have had a bone marrow transplant  Open a glossary item
  • have HIV
  • have hepatitis B or hepatitis C
  • have any medical condition or mental health problem that the trial team think could affect you taking part
  • take an amount of drugs or drink an amount of alcohol that is a concern for your doctor

Other

You cannot join this trial if any of these apply. You:

  • are pregnant or breastfeeding
  • are sensitive to olaparib or anything it contains
  • have had a whole blood transfusion in the last 4 months, or you have had a red blood cells transfusion in the last month
  • are involved on the planning or running of this trial

Trial design

This is an international phase 2 trial. Researchers hope that around 370 people worldwide and 9 people from the UK will agree to take part.

Everyone taking part has olaparib as tablets that they swallow whole, twice a day. You continue to take olaparib for as long as it works and the side effects aren’t too bad. 

Quality of life

Everybody taking part completes quality of life questionnaires before the start of treatment and:

  • every 8 weeks for a year
  • then every 3 months for as long as you are having treatment
  • at the end of treatment
  • a month after the end of treatment

The questionnaires ask about how you have been feeling and what side effects you have had.

Blood tests

You have extra blood tests as part of this trial. You have them before the start of treatment and then:

  • at set times during the trial
  • at the end of treatment or if your cancer gets worse

Researchers want to look for certain proteins (biomarkers Open a glossary item) that can help to tell how well the treatment is working and find out what happens to olaparib in your body.

Tissue sample

The trial team will ask to use a tissue sample of your cancer taken when you had surgery or a biopsy. You need to have a new tissue sample taken if there isn’t a suitable sample available.

Doctors want to check whether you have changes (mutations) in the homologous recombination repair genes.

Doctors may also ask you to have a new tissue sample taken if your cancer gets worse. You don’t have to agree to this if you don’t want to. You can still take part in this trial.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

During treatment, you see the trial team every month. You have blood tests and a physical examination every time you see them.

You have a CT scan, MRI scan or bone scan every 2 months, for a year. You then have a CT scan, MRI scan or bone scan every 3 months. This continues for as long as the treatment is helping you and the side effects aren’t too bad.

When you finish treatment, you see the trial team after a month. You then see or speak with the trial team:

  • every 2 months for a year
  • then every 3 months until the end of this trial

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the treatment.

The most common side effects of olaparib are:

We have more information about the possible side effects of olaparib.

Location

Manchester
Newcastle upon Tyne
Oxford
Sheffield

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. Ruth Plummer

Supported by

Merck, Sharp & Dohme

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16262

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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