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

Plain-language summary

This study evaluates pharmacokinetically boosting the cancer drug Olaparib by giving it together with Cobicistat, in order to improve its effect and tolerability. It enrolls patients aged 18 and older who are receiving Olaparib tablets 300 mg twice daily. It is a Phase 4 study and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Recruiting

Sponsor

Radboud University Medical Center

Intervention

Olaparib, Cobicistat

Start date

12/15/2021

Estimated completion

12/31/2025

Countries

Netherlands

Related genes

Locations

• 's-Hertogenbosch, Netherlands
• Amsterdam, Netherlands
• Amsterdam, Netherlands
• Breda, Netherlands
• Groningen, Netherlands
• Leiden, Netherlands
• Maastricht, Netherlands
• Nijmegen, Netherlands
• Rotterdam, Netherlands
• Utrecht, Netherlands

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.