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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Amphia Hospital Breda The Netherlands
Tergooiziekenhuizen Hilversum The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Meander Medical Center Amersfoort The Netherlands
Bravis Ziekenhuis Roosendaal The Netherlands
Lpmhk Ubhkjliuovzs Mfgvxow Cwivkbg (fbvvh Leiden The Netherlands
Urthilrescqt Mybgoaz Cwavxeq Gtcjnuaeq Groningen The Netherlands
Afnrvwkcb Ujg Amsterdam The Netherlands
Exiweyn Uzxiecbqjqdy Mldycil Cepyoxo Rfwgzovqf (nihypjx Mcu Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.02.2022

Trial locations

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.

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.

Trial ID:
2024-516414-38-00
NCT ID:
NCT05078671
Trial Phase:
Human Pharmacology (Phase I) – Other

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