A study looking at rucaparib for solid tumours including ovarian cancer

Cancer type:

All cancer types

Ovarian cancer

Secondary cancers

Status:

Results

Phase:

Phase 1/2

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.

Solid tumours Open a glossary item are any type of cancer apart from blood cancers such as leukaemia. The trial included women who had cancer of the ovary , fallopian tube cancer or primary peritoneal cancer. Doctors treat these cancers in the same way. So, when we use the term ovarian cancer in this summary, we are referring to all 3.

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 BRCA1 Open a glossary item and BRCA2 mutations wouldn’t be able to repair themselves and would die.

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 1 or 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.

Results
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 pharmacokinetics Open a glossary item

Side effects
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 (anaemia )
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.

Conclusion
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 (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the study team who did the research. We have not analysed the data ourselves.