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A study looking at rucaparib for solid tumours including ovarian cancer
This study looked at a drug called rucaparib for people who had solid tumours. It was for people whose cancer had grown into surrounding tissue or spread elsewhere in the body. This is locally advanced or advanced cancer.
This study was open for people to join between 2011 and 2016. Some results were published in 2017 and some in 2018.
More about this trial
The usual treatment for ovarian cancer that has spread is surgery and chemotherapy. Doctors were looking for ways to improve treatment. In this study, they looked at a drug called rucaparib.
Rucaparib is a type of drug known as a PARP inhibitor. PARP is an enzyme that helps damaged cells to repair themselves. Cancer cells with gene changes already have problems repairing themselves. The researchers hoped that by blocking PARP, cancer cells with
In this study people had rucaparib as a tablet.
The main aims of this study were to:
- find the best dose of rucaparib to have as a tablet
- find out what happens to rucaparib in the body
- learn more about the side effects
Summary of results
The researchers found the best dose of rucaparib for people with solid tumours. They found this dose worked for women with advanced ovarian cancer who had a BRCA gene change in their cancer cells. And the side effects were manageable.
About this study
There were 3 parts to this study:
- part 1 was for people who had any type of solid tumour
- part 2 was for women who had ovarian cancer with a change (
mutation)in the ovarian cancer cells called BRCA 1or BRCA 2
- part 3 was for people with any type of solid cancer that had a change in the BRCA genes
In part 1 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. And so on, until they found the best dose to give. This is called a dose escalation study.
When the study team found this dose then part 2 and part 3 of the study began.
56 people joined part 1 and had different doses of rucaparib. Some people had it once a day and some had it twice a day. Some people had it with food and some people had it without food.
In part 1 the researchers found:
- the best dose – this was 600mg of rucaparib twice a day
- you can have rucaparib with or without food
42 women joined part 2. Everyone had ovarian cancer with a BRCA 1 or BRCA 2 gene change in the cancer cells. They all had 600mg of rucaparib twice a day. The team looked to see if treatment worked. They had the results for 39 women.
They found in:
- 4 women the cancer went away completely – this is called a complete response
- 21 women the cancer went away a little bit – this is called a partial response
- 12 women the cancer stayed the same
- 2 women the cancer got worse
26 people joined part 3. They all had 600mg rucaparib twice a day. The team looked in more detail at what happened to rucaparib in the body. This is called
The researchers looked at the side effects in the different groups. They found that the most common side effects of rucaparib in part 1 and 3, that is those in the groups with any type of solid tumour, were:
- feeling sick or being sick
- fatigue (tiredness)
- a drop in the number of red blood cells (
- loss of appetite
The most common side effects of rucaparib in women with ovarian cancer were:
- liver changes
- constipation or diarrhoea
- loss of appetite or taste changes
- tummy (abdominal) pain
- shortness of breath
- increased risk of bleeding
- high levels of a chemical in the blood called creatinine
Most of the side effects were manageable. Some people had to stop treatment for a short time until the side effect got better. Or the study team reduced their dose.
The researchers found the best dose of rucaparib to give. They concluded it worked for women with ovarian cancer with a change in BRCA 1 or BRCA 2. And the side effects were manageable.
There are more trials running looking at rucaparib for ovarian cancer.
Where these results come from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (
How to join a clinical trial
Dr Rebecca Kristeleit
Clovis Oncology Inc
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer