Improving olaparib treatment for cancer patients

Pharmacokinetic Boosting of Olaparib to Improve Exposure, Tolerance and Cost-effectiveness

This study is testing if adding cobicistat to olaparib treatment can help cancer patients feel better and make the medication more affordable.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radboud University Medical Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 10 sites ('s-Hertogenbosch and 9 other locations)
• Trial ID: NCT05078671 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetic enhancement of olaparib, a PARP inhibitor, to improve its exposure, tolerance, and cost-effectiveness for patients with various types of cancer. It aims to assess the effectiveness of olaparib in combination with cobicistat, focusing on patients who are already on olaparib treatment or are starting it. The study will evaluate the outcomes based on the patients' performance status and treatment duration, ensuring a comprehensive understanding of the drug's impact on health care costs and patient accessibility.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are starting or currently on olaparib treatment and meet specific performance status criteria.

Not a fit: Patients currently using other anti-cancer therapies or those with contraindications for cobicistat may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could make olaparib treatment more affordable and accessible for a larger population of cancer patients.

How similar studies have performed: Other studies have shown promising results with pharmacokinetic enhancements in cancer treatments, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Subjects who are able and willing to provide written informed consent prior to screening;
* Age of 18 years or older;
* Able to measure the outcome of the study in this subject.

Part A:

* Subjects who start or are on treatment with olaparib tablets 300mg twice daily, according to the drug label and physician's discretion;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Part B:

* Subjects who start on treatment with olaparib tablets 300mg twice daily, according to the drug label and physician's discretion;
* Expected to be on olaparib treatment for ≥ 3 months;
* ECOG performance status of 0-3.

Exclusion Criteria:

* Concurrent use of other anti-cancer therapies;
* Concurrent use of potent inducers or inhibitors of the cytochrome p450 enzyme 3A3 (CYP3A4) as assessed with the Dutch drug database "G-Standaard" of the Royal Dutch Pharmacists Association(KNMP);
* Known contra-indications for treatment with cobicistat in line with the summary of product characteristics;
* Subjects with renal insufficiency defined as estimated glomerular filtration rate \< 50 ml/min.

Where this trial is running

's-Hertogenbosch and 9 other locations

• Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands (Recruiting)
• Amsterdam Universitair Medische Centra — Amsterdam, Netherlands (Recruiting)
• Netherlands Cancer Institute-Antoni van Leeuwenhoek — Amsterdam, Netherlands (Recruiting)
• Amphia Ziekenhuis — Breda, Netherlands (Recruiting)
• Universitair Medisch Centrum Groningen — Groningen, Netherlands (Recruiting)
• Leiden University Medical Center — Leiden, Netherlands (Recruiting)
• Maastricht UMC — Maastricht, Netherlands (Recruiting)
• Radboudumc — Nijmegen, Netherlands (Recruiting)
• ErasmusMC — Rotterdam, Netherlands (Recruiting)
• Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (Recruiting)

Study contacts

• Principal investigator: Nielka van Erp, prof. PharmD PhD — Radboud University Medical Center
• Study coordinator: Joanneke K Overbeek, PharmD

Conditions Cancer; olaparib; pharmacokinetic enhancement