A trial of olaparib for ovarian cancer that has come back (MOLTO)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Ovarian cancer

Status:

Closed

Phase:

Other

This trial is for women with ovarian cancer that has come back after having platinum chemotherapy and who have a mutation in a gene called BRCA1 or BRCA2.

It is for women who have:

These cancers are treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all 3. 

More about this trial

Ovarian cancer is often treated with a platinum based chemotherapy Open a glossary item. Platinum chemotherapy includes the drugs: 

After some time, ovarian cancer may start to grow again. This is called recurrence Open a glossary item

Researchers are looking for new treatments to stop ovarian cancer from coming back. In this trial, they are looking at a drug called olaparib

Olaparib is a cancer drug called a PARP inhibitor. It blocks an enzyme Open a glossary item called PARP, which helps damaged cancer cells to repair themselves.     

Doctors think that if they stop PARP working, the cancer cells will not be able to repair themselves. 

The main aim of this trial is to find out how well olaparib stops ovarian cancer from coming back (recurring). 

Who can enter

The following bullet points list the entry conditions for this trial. Please talk to your doctor or the trial team if you are unsure about any of these as 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 ovarian cancer that has come back (recurred) and that is likely to grow quickly (high grade serous or an endometrioid type)
  • You have a mutation Open a glossary item in either the BRCA1 Open a glossary item or BRCA2 Open a glossary item gene. Your doctor can check this for you
  • You have at least 1 area of cancer that can be seen and measured on a scan
  • You can swallow and absorb tablets 
  • You have satisfactory blood tests results
  • Your heart and kidneys are working well
  • You are well enough to be up and about for at least half of the day (performance status 0 to 2
  • You are at least 18 years old
  • You are willing to use reliable contraception during treatment and for 1 month after completing treatment, if there is any possibility you could become pregnant

Who can’t take part
You cannot join this trial if any of these apply. 

Cancer related

  • Your cancer has spread to your brain and this is causing you problems 
  • You have, or doctors think you may have, acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)
  • You are going to have treatment with bevacizumab (Avastin)
  • You have had chemotherapy, radiotherapy or a tumour embolisation Open a glossary item 3 weeks before the start of platinum chemotherapy
  • You have had major surgery in the last 2 weeks and you still have side effects from it 
  • You have moderate or severe side effects from previous anti cancer treatment, apart from hair loss and problems with your nerves 
  • You are having any other anti cancer treatment
  • You have had another cancer in the past 5 years apart from carcinoma in situ Open a glossary item of the cervix or breast, basal cell or squamous cell skin cancer, a small cancer (stage 1) of the womb or any other stage 1 solid  tumour Open a glossary item that has been successfully treated 

Medical conditions

  • Your doctor thinks you are at high risk of developing a blockage in the bowel (bowel obstruction) or a tear in the bowel wall (bowel perforation) 
  • You have heart problems including high blood pressure that is not controlled by medications, an irregular heartbeat (arrhythmia), or you have had a heart attack in the last 6 months  
  • You have had a blood clot in an artery or a stroke Open a glossary item in the last 6 months. You may be able to take part if it was a deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • You have high levels of protein in the urine 
  • You have spinal cord compression Open a glossary item that is not controlled 
  • You have a lung condition called interstitial lung disease
  • You have fits (seizures) 
  • You have taken drugs that affect enzymes called CYP3A in the last 2 to 5 weeks. Your doctor can check this for you and may be able to change these drugs if needed
  • You have HIV, hepatitis B or hepatitis C 
  • You have had an experimental treatment as part of another clinical trial in the past month
  • You are unable to take a drug called cediranib for any reason 
  • You are sensitive to the drug olaparib or anything it contains 

Other

  • You are pregnant or breastfeeding 

Trial design

This is a phase 2 trial. Researchers hope that around 20 women going to the Christie Hospital in Manchester will take part. 

All women have chemotherapy with either carboplatin or cisplatin, alongside another chemotherapy drug. It can be:

This will be the 1st course of platinum based chemotherapy treatment. 

After chemotherapy, you have a CT scan to find out how well the treatment worked. If the cancer got smaller, or can’t be seen on the CT scan, you have olaparib tablets. 

You start taking olaparib 4 to 8 weeks after finishing the 1st platinum based chemotherapy. Olaparib is a tablet that you take twice a day. You continue taking olaparib until the tumour comes back (recurrence). 

When the tumour comes back, you have more chemotherapy with either carboplatin or cisplatin, alongside another chemotherapy drug (gemcitabine, paclitaxel or liposomal doxorubicin). This will be the 2nd course of platinum based chemotherapy treatment on this trial.    

After the 2nd chemotherapy treatment, you have a CT scan to find out how well the treatment worked. If the cancer got smaller or can’t no longer be seen on the CT scan, you have either:

  • olaparib again if you have finished the 1st course of olaparib treatment more than 6 months after completing the 1st platinum-based chemotherapy (platinum sensitive)
  • olaparib again alongside another targeted anti cancer drug called cediranib if you finished the 1st course of olaparib treatment less than 6 months after completing the 1st platinum based chemotherapy (platinum resistant)

You stop the trial treatment if your cancer doesn’t get smaller, or if it increases in size, after the 1st or 2nd platinum based chemotherapy.

 study diagram

Women who have had olaparib treatment as part of another clinical trial may also be able to join the MOLTO trial. They can have olaparib again, or olaparib alongside cediranib, if their cancer gets smaller or cannot be seen on the CT scan after their 2nd platinum based chemotherapy treatment.

Tissue and blood samples 
Everyone taking part will need to give a tissue sample (biopsy) of their cancer before the 1st and 2nd platinum-based chemotherapy treatment. 

You will also be asked to give blood samples before the 1st and 2nd platinum based chemotherapy. The researchers want to:

  • look for changes in cancers genes 
  • find out why these treatments work better for some people and not others

Hospital visits

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

  • physical examination
  • blood tests
  • urine test 
  • heart trace (ECG Open a glossary item)
  • a kidney test called a glomerular filtration rate test (GFR) Open a glossary item
  • a CT scan 

After starting olaparib you see the trial doctor every month. This is for blood tests and a physical examination. 

You also have a CT scan every 3 months while taking olaparib. 

After you finish treatment, you will continue to see the trial team at the Christie Hospital in Manchester for another 3 months. 

Side effects

The trial team monitors you while you are having treatment and between treatments. They will give you a phone number to contact the trial team if you are worried about anything. 

The most common side effects of olaparib are: 

We have more information about the side effects of olaparib

The most common side effects of cediranib are: 

  • diarrhoea
  • high blood pressure
  • fatigue
  • infection such as urinary infection
  • a drop in the number of blood cells causing an increased risk of infection and bleeding
  • thyroid problems
  • blood clots
  • problems healing wounds
  • increase in the levels of protein in the urine 

We also have information about the side effects of: 

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

Professor Gordon Jayson

Supported by

AstraZeneca
Manchester Academic Health Sciences Centre Trials Coordination Unit  
The Christie NHS Foundation Trust 

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14574

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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