Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07069335

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

19 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, Songpa District, 05505, South Korea

Location status: Recruiting

Location contact

CONTACT

01034379425

About this study

This study will be conducted in two stages. Stage 1 enrolls patients who have been taking BR2022-1 as existing therapy, and results will be evaluated before deciding whether to proceed with the Stage 2 part of the study and enroll more patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Olaparib 150 MG

Drug

Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration

Other names: BR2022

Primary outcomes

  1. Pharmacokinetic variable - Cmax

    Time frame: From Day 6 to Day 7 after dose administration

    Maximum plasma concentration of BR2022 and BR2022-1

  2. Pharmacokinetic variable - AUCtau

    Time frame: From Day 6 to Day 7 after dose administration

    Area under the drug concentration-time curve over the time interval from Day 6 to Day 7 after dose administration

Study contacts

Contact information is provided by the study sponsor or research team.

Shinyoung Oh

CONTACT

[email protected]

+82 2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Multi-centre, Open-Label, Randomized, Two-Stage, Two-treatment, Two-Period, Multiple-Dose, Crossover Bioequivalence Study to Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.