Study Comparing the Pharmacokinetics and Safety of BR2022 and BR2022-1 in Female Patients with BRCA-Mutated Advanced Ovarian Cancer Using Olaparib Treatment

What this Trial Is About

Researchers are evaluating the pharmacokinetics and safety of two formulations, BR2022 and BR2022-1, in females with advanced ovarian cancer who have deleterious or suspected deleterious germline BRCA mutations. This Phase 1, multicenter, open-label, randomized, crossover bioequivalence study aims to compare these treatments in patients already on olaparib therapy, focusing on their drug absorption and safety profiles. The study is conducted in two stages. Stage 1 enrolls patients currently taking BR2022-1 as therapy, with results reviewed before proceeding to Stage 2. Participants are randomized into two groups one receives the test treatment BR2022 150 mg olaparib for 7 days followed by the reference treatment BR2022-1 for 7 days, and the other group receives the treatments in reverse order. There is no washout period between treatments. Participants will be monitored through blood tests measuring pharmacokinetic variables such as peak drug concentration and overall drug exposure from days 6 to 7 after dosing. Safety assessments will be conducted throughout. The total participation lasts for about two weeks, with careful observation of drug effects and safety in this crossover design. The study is led by Boryung Pharmaceutical Co., Ltd.

A Bioequivalence Study to Evaluate Pharmacokinetics and Safety of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer