A trial looking at olaparib for advanced solid tumours including breast or ovarian cancer in people with BRCA gene faults

Cancer type:

All cancer types

Status:

Results

Phase:

Phase 1

This trial was looking at a new drug called olaparib (also known as AZD2281) for people with solid tumours Open a glossary item . It was for people who had advanced cancer with a change to a BRCA gene.

Every cell contains DNA. This is the genetic information which controls how cells behave. If DNA becomes damaged (as in cancer cells), a protein called PARP-1 helps to repair it. Olaparib is a drug that stops PARP-1 from working. It is called a PARP-1 inhibitor. If PARP-1 doesn’t work, cancer cells can’t repair themselves and they die.

Up until this study, researchers had used capsules of olaparib in clinical trials. But people had to take a lot of capsules each day to get the full dose. And the capsules were quite large. In this trial, the researchers were looking at a new tablet form of the drug.

The aims of the trial were to

Compare the amount of olaparib that is absorbed into the bloodstream when you have it as tablets, compared to capsules
Learn more about the side effects
See whether the tablet forms of olaparib helped people as much as the capsule form of the durg

Summary of results

The trial team found that the same amount of olaparib could be absorbed into the body by taking fewer, smaller tablets.

The first part of the trial recruited 24 people with advanced solid tumours who also had changes (mutations Open a glossary item ) to a BRCA gene.

They took different doses of olaparib firstly as capsules and then a few days later as tablets. The researchers looked at what happened to the drug in the body. This is called pharmacokinetics Open a glossary item . More specifically, they measured how much of the drug reached the bloodstream (bioavailability).

The researchers found that the same amount of olaparib was available in the bloodstream when people took fewer, smaller tablets.

The researchers then looked at different ways of taking olaparib tablets. In this part of the trial, there were 62 people who had breast or ovarian cancer with a BRCA gene mutation. They were put into treatment groups at random and had 1 of the following

Olaparib tablets 3 times a day every day
A higher dose of olaparib tablets 4 times a day every day
Olaparib tablets 3 times a day for 2 weeks, followed by a week without taking the tablets (intermittent dosing)
A higher dose of olaparib twice a day for 1 week, followed by 2 weeks without taking the tablets (intermittent dosing)

The researchers found that 3 of these treatment plans helped people as much as taking the capsules.

The side effects included

Tiredness (fatigue)
Feeling or being sick
Loss of appetite
Diarrhoea
A drop in the number of red blood cells causing tiredness and breathlessness

But apart from the group who had the higher intermittent dose, people found the side effects acceptable.

The researchers recommended that in future trials, olaparib tablets taken twice a day should be used instead of capsules.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) but may not have been published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.