Recruiting

Study of Lower Dose Olaparib Combined with Cobicistat to Improve Treatment Tolerance in Cancer Patients

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating patients with cancer using a combination of two medications: olaparib and cobicistat. The purpose is to determine if using a lower dose of olaparib together with cobicistat can work as effectively as using olaparib alone at its regular dose. Olaparib is a medication used to treat certain types of cancer, while cobicistat is a substance that can help prevent olaparib from being broken down in the body too quickly.

The study involves taking both medications by mouth. Patients will receive either the standard dose of olaparib alone or a reduced dose of olaparib combined with cobicistat. The maximum daily dose of olaparib will be 600 milligrams, while cobicistat will be given at up to 300 milligrams per day. The treatment may continue for an extended period, depending on how well it works for each patient.

During the study, doctors will monitor how the medications work together in the body and track any side effects that patients may experience. This research aims to find out if using the combination of medications at lower doses could make the treatment more tolerable for patients while potentially reducing its cost.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period
You will begin taking olaparib tablets at the regular prescribed dose according to your doctor's instructions.
This medication is taken by mouth for the treatment of cancer.
Step 2
Part A - First assessment period
After starting treatment, you will continue taking olaparib for one week.
Following this week, blood samples will be collected at specific times throughout a 12-hour period:
Samples will be taken before taking the medication, and then at 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, and 8 hours after taking olaparib.
When possible, additional samples may be collected at 10 and 12 hours.
Step 3
Modified treatment period
You will receive a reduced dose of olaparib combined with cobicistat.
Both medications are taken by mouth.
This combination will continue for one week.
Step 4
Second assessment period
After one week of the combined treatment, another series of blood samples will be collected.
The sampling schedule will be the same as in step 2.
Step 5
Part B - Extended monitoring
If you continue to part B of the study, you will be monitored for at least 3 months.
During this time, your doctor will track how well you tolerate the medication.
Any needs for dose adjustments due to side effects will be recorded.

Who can join the trial?

8 criteria

Must be 18 years or older
Must be able and willing to provide written informed consent before screening procedures begin
Must be either starting or currently receiving treatment with olaparib tablets as prescribed by their doctor
Must have a performance status of 0-3 on the ECOG scale (a measure of how well you can perform daily activities and care for yourself)
Must be available for the study duration and willing to undergo required blood sample collections
For long-term participation, must be expected to continue olaparib treatment for at least 3 months
Must be able to complete all required study measurements and attend scheduled visits
Must be willing to undergo blood sampling for studying how the medication works in your body (PK) and its effects (PD)

Who cannot join the trial?

14 criteria

Age under 18 years old
Inability to give informed consent
Pregnancy or breastfeeding
Known allergic reaction to olaparib (the study medication) or similar drugs
Severe liver problems (as this may affect how the medication is processed in your body)
Severe kidney problems (as this may affect how the medication is cleared from your body)
Active uncontrolled infections
Any other serious medical condition that could affect participation in the study
Current participation in other clinical trials
History of poor compliance with medical treatments
Unable to swallow medications in tablet form
Mental conditions that could interfere with understanding study requirements
Life expectancy less than 16 weeks
Use of medications that could interact with olaparib

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Olaparib
is a medication used to treat certain types of cancer. It works by blocking an enzyme that cancer cells need to repair their damaged DNA, which can help stop the cancer from growing. In this trial, researchers are studying how to optimize the dosing of olaparib by using a "boosting" approach, which means combining it with another substance that could help the body process the medication more effectively. This could potentially allow for lower doses while maintaining the same treatment effectiveness.
Pharmacokinetic booster
(although not specifically named in the trial information) would be a substance used to enhance how the body processes olaparib. This approach is being studied to potentially improve how well patients tolerate the treatment while making it more cost-effective.

What is already known about the treatment

Olaparib - An oral medication administered in tablet form that belongs to the class of PARP (poly ADP-ribose polymerase) inhibitors used in cancer treatment. This targeted therapy works by blocking DNA repair in cancer cells, making them more vulnerable to destruction, particularly in patients with specific genetic mutations like BRCA1 and BRCA2. Olaparib is primarily used in the treatment of various types of cancer, including ovarian, breast, pancreatic, and prostate cancers, and has shown significant effectiveness in clinical trials as both a maintenance therapy and treatment option. The medication represents an important advancement in precision medicine, as it specifically targets cancer cells while generally sparing healthy cells, which typically results in fewer side effects compared to traditional chemotherapy.

Investigated diseases

Cancer - A disease characterized by abnormal cell growth where cells divide uncontrollably and can invade nearby tissues. Cancer develops when the body's normal control mechanism stops working, causing old cells to multiply uncontrollably instead of dying. These cells can form lumps or masses of tissue called tumors, which can grow and interfere with normal body functions. Cancer cells can break away from tumors and travel through the blood or lymph system to other parts of the body. The disease can start almost anywhere in the human body and can affect various organs and tissues.