A trial looking at olaparib for people with advanced solid tumours
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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 
or .
It is for people who have changes () 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 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.
Please note, the trial is now only open to people with breast cancer.
The main aims of this trial are to:
- find out how well olaparib works for advanced cancers
- see if olaparib improves treatment
- learn more about the side effects of olaparib
Who can enter
The following bullet points summarise 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.
Please note, there are 3 treatment groups (cohorts) in this trial. Only the breast cancer cohort is open for people to join. There are specific entry conditions and we haven't listed them all. Your doctor will check to see if you are suitable to join.
Who can take part
You may be able to join this trial if all of the following apply:
- you have breast cancer that has spread to other parts of the body (
metastatic breast cancer ) - your doctor thinks that you can’t have treatment to try to cure your cancer
- you have satisfactory blood tests results
- you have changes ( somatic mutations) in the breast cancer susceptibility genes. Your doctor can tell you more about this.
- have had chemotherapy with an of
anthracycline drug such as doxorubicin or epirubicin and a taxane drug such as paclitaxel or docetaxel. Your doctor checks all previous treatments to see if you are suitable to take part. - 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 had more than 2
courses of chemotherapy for cancer that has spread to another part of the body - you have had olaparib or any other similar drug
- you have had radiotherapy within 2 weeks or if you haven't fully recovered from its side effects or if you have
pneumonitis that radiotherapy can cause - you have had recent treatment with a drug to treat cancer such as a
targeted treatment or chemotherapy within 3 weeks - you have another cancer that is getting worse or that needed treatment in the past 5 years, apart from
non melanoma skin cancer or carcinoma in situ of the cervix or breast that has been successfully treated - 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 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 disease
- 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 - 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 in the planning or running of this trial
Trial design
This is an international phase 2 trial. Researchers hope that around 390 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 () 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 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 6 weeks for the first 6 months after you start study treatment. After that, you have them every 3 months for as long as you are having treatment.
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:
- a drop in the number of red blood cells causing shortness of breath, tiredness, fast heartbeat and looking pale
- a drop in the number of white blood cells causing an increased risk of infection
- feeling or being sick
- tiredness (fatigue)
- indigestion
- loss of appetite
- headaches
- taste changes
- dizziness
- loose or watery poo (diarrhoea)
- cough
We have more information about the possible side effects of olaparib.
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.
Chief Investigator
Professor Ruth Plummer
Supported by
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
