PROACTIVE

Principal investigator

Dr. F.L. Opdam

Medication

Olaparib

Summary

"Reason for the study: Olaparib is a drug that inhibits the growth of cancer. It is used in various types of cancer to control the cancer. Olaparib is administered at a standard dose of 300 mg twice daily (2 tablets of 150 mg). Cobicistat is a drug that inhibits the breakdown of drugs in the body. As a result, a lower dosage is sufficient to achieve the same effect. Cobicistat is not a new medicine. It is currently used to inhibit the breakdown of HIV drugs in the body. Cobicistat is also expected to inhibit the breakdown of Olaparib. As a result, a lower dose of Olaparib with Cobicistat may work just as well as the standard dose of Olaparib. A lower dose of Olaparib is cheaper. In addition, Cobicistat can ensure that there are fewer fluctuations in the amount of Olaparib that people have in their blood. As a result, fewer people may suffer from side effects of the Olaparib.

What is being investigated?
It is being investigated what dose of Olaparib in combination with Cobicistat is needed to get the same amount of Olaparib in the blood as the normal dose of Olaparib. A total of 18 patients will participate in the PROACTIVE-A study. These are patients who receive 300 mg of Olaparib 2 times a day. Olaparib can be used for different types of cancer, namely ovarian cancer, breast cancer, pancreatic cancer or prostate cancer. With this knowledge, it will be possible to investigate in a larger group of patients in the future whether the lower dose of Olaparib with Cobicistat works as well in the long term and is at least as well tolerated as the standard dose of Olaparib (PROACTIVE-B study).

What is the study treatment?
In this study, patients will receive one week of standard treatment and one week of study treatment, consecutively. The standard treatment consists of 300 mg Olaparib 2 times a day. The study treatment consists of a low dose of Olaparib of 100 mg twice a day combined with 150 mg 2 times a day."

Read more on heyleys.nl and clinicaltrials.gov

Patient population

Tumor type: ovarian cancer, ovarian carcinoma/breast cancer, breast carcinoma/prostate cancer, prostate carcinoma
Tumor characteristics: Olaparib in standard of care