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

Not Applicable

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: Olaparib 150 MG

• Registration Number: NCT07069335
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-06-17
• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-05-15
• Study Completion: 2026-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

1. Females aged 19 -74 at the time of consent
2. Those who voluntarily signed the informed consent to participate in this study
3. 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

1. 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
2. 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
3. Those who are pregnant, suspected of pregnancy, or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1 (TR)	Olaparib 150 MG	Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 1, subjects receive T (1d-7d) then R (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None
Sequence 2 (RT)	Olaparib 150 MG	Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 2, subjects receive R (1d-7d) then T (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic variable - Cmax	From Day 6 to Day 7 after dose administration	Maximum plasma concentration of BR2022 and BR2022-1
Pharmacokinetic variable - AUCtau	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa District, Korea, Republic of