A trial looking at rucaparib for solid tumours including ovarian cancer

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:

Phase 1/2

This trial is looking at a new drug called rucaparib for people who have solid tumours including ovarian cancer that has grown into surrounding tissue or spread to another part of the body. This trial is in 2 parts. The 1st part included people with any type of solid tumour Open a glossary item. The 2nd part is for women who have ovarian cancer with a change (mutation Open a glossary item) in the BRCA1 or BRCA2 genes. 

More about this trial

Doctors usually treat ovarian cancer that has spread with surgery and chemotherapy.

Rucaparib is a type of drug known as a PARP inhibitor. PARP is an enzyme that helps damaged cells to repair themselves. If PARP is blocked, cancer cells may not be able to repair themselves.

You can have rucaparib as an injection into a vein or as a tablet. In this trial you will have rucaparib as a tablet.

The aims of this trial are to find out

  • The highest dose of rucaparib that you can safely have as a tablet (in the 1st part of the trial). This dose has been chosen for Part 2 of this trial
  • More about the side effects and how rucaparib works in the body
  • How well rucaparib works

Who can enter

This trial is in 2 parts. The 1st part was for people who had any type of solid tumour that had come back or had spread to another part of the body. Please note – this part of the trial is now complete.

The 2nd part of the trial is for women who have ovarian cancer with a change (mutation Open a glossary item) in the BRCA1 or BRCA2 genes. This part has been extended.

For the extended 2nd part of this trial you must

  • Have ovarian cancer with a fault in the BRCA 1 or BRCA 2 gene
  • Have had at least 3 types of chemotherapy
  • Have cancer that has currently come back or had come back within at least 6 months after your first chemotherapy tretament

As well as the above

  • You have satisfactory blood test results
  • Your heart works well enough -  your doctor will test for this
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot enter either part of this trial if you

  • Have cancer that has spread to your brain or spinal cord and is causing symptoms – you may take part if you have no symptoms and the cancer has been stable for the last month
  • Have had another PARP inhibitor apart from iniparib
  • Have had another anti cancer treatment in the last 2 weeks
  • Have had an experimental drug as part of another clinical trial in the last 2 weeks
  • Have had surgery in the last 5 days
  • Have a serious heart problem
  • Have another cancer uless it was successfully treated more than 6 monhts ago
  • Have problems with your digestive system Open a glossary item that would make it difficult for you to absorb tablets
  • Are taking medications that could affect the way rucaparib works – your doctor can advise about this
  • Are HIV, hepatitis B or hepatitis C positive
  • Have any other condition that could affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This phase 1/2 trial is in 2 parts.

Part 1 recruited people who had solid tumours. The first few people taking part had a low dose of rucaparib. If they didn’t have any serious side effects, the next few had a higher dose of rucaparib. And so on, until they found the best dose to give. This is called a dose escalation study.

In part 1 the researchers also found out if food could affect how much rucaparib your body absorbed. To do this they asked a small number of people on a day when they attended the clinic not to eat for at least 10 hours before and 2 hours after taking their rucaparib. A week later they fasted for at least 10 hours and then ate a high calorie, high fat breakfast.

Part 2 will recruit about 80 people with ovarian cancer that is locally advanced or has spread to another part of the body. They will have rucaparib at the highest safe dose found in part 1. In this part of the study, the researchers want to learn more about the side effects and whether rucaparib helps people with ovarian cancer that is locally advanced or has spread to another part of the body.

You take rucaparib tablets twice a day. You can take rucaparib with or without food.

As long as you don’t have bad side effects, you can carry on taking rucaparib for as long as your doctor thinks it is still helping you.

For a week before starting rucaparib, and while taking it, you must not eat grapefruit, anything containing grapefruit, drink grapefruit juice or take the herbal supplement St John’s Wort. This is because they can affect the way rucaparib works in your body.

Hospital visits

You will see the doctor and have some tests before you start treatment. The tests include

  • A physical examination
  • Blood and urine tests
  • Heart trace (ECG Open a glossary item)
  • CT scan or MRI scan

During, and after treatment you see the doctor regularly and have the same tests. You have a CT scan or MRI scan every 6 to 9 weeks.

The trial team will continue to monitor you to see if your cancer comes back.

Side effects

Rucaparib is a new drug and there may be side effects we don’t know about yet. The most commonly reported side effects include

Your doctor will talk to you about the possible side effects before you agree to take part in the study.

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

Dr Rebecca Kristeleit

Supported by

Clovis Oncology Inc
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9376

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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