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

Recruiting now · Phase 1

Conditions studied: Ovarian Cancer

In brief

This was a multicenter, open-label, randomized, crossover bioequivalence study to evaluate the pharmacokinetics and safety of BR2022 and BR2022-1 in Patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer.

Key facts

Study ID

NCT07069335

Run by

Boryung Pharmaceutical Co., Ltd

People needed

24

Starts

2025-06-17

Expected to finish

2026-05-15

Last updated by the study team

2025-07-16

Who can join

Age: 19 and older, up to 74. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females aged 19 -74 at the time of consent
• Those who voluntarily signed the informed consent to participate in this study
• Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been taking stable doses of olaparib for more than 3 months before screening.

You may not qualify if…

• Those who have a history of severe hypersensitivity to drugs that include the ingredients of the investigational product or have a history of clinically significant hypersensitivity reactions
• Those who have gastrointestinal disorders (e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or have had surgeries (excluding appendectomy or hernia surgery) that may affect the absorption of the investigational products
• Those who are pregnant, suspected of pregnancy, or nursing

Where it is running

• Asan Medical Center — Seoul, Songpa District, South Korea (enrolling)

Full record on ClinicalTrials.gov

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