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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Oct 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to use the cancer treatment olaparib, which is typically given at a standard dose of 300mg twice daily. The researchers want to see if they can safely lower the dose of olaparib by combining it with another medication called cobicistat. This combination might allow patients to receive a smaller amount of olaparib while still getting the same benefits. The goal is to make the treatment more affordable and easier for patients without compromising its effectiveness.

To participate in the trial, you need to be at least 18 years old and able to give your consent to join. You should also be starting or currently receiving olaparib treatment. Depending on which part of the study you join, your health can be rated from good to moderate, but you shouldn’t be using other cancer treatments or certain medications that affect how olaparib is processed in your body. If you join this trial, you'll help researchers learn more about whether this new approach can be safely used in everyday practice, which could make treatment options better and more cost-effective for patients in the future.

Gender

ALL

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.