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

NCT07069335 — Phase 1, Recruiting, 24 participants, Boryung Pharmaceutical Co., Ltd

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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

Registry	NCT07069335
Status	Recruiting
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	24 (Estimated)
Sponsor	Boryung Pharmaceutical Co., Ltd (Industry)
Conditions	Ovarian Cancer
Interventions	Olaparib 150 MG (Drug)
Dates	start 2025-06-17, primary completion 2026-05-15 (estimated), completion 2026-05-15 (estimated), first posted 2025-07-16, last updated 2025-07-16
Locations	1 site in South Korea

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Sequence 1 (TR)	Experimental	Drug: 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)	Experimental	Drug: 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

Olaparib 150 MG (Drug), also known as BR2022: Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: Female, ages: 19 Years to 74 Years

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

+Locations (1)

Facility	City	Country	Status
Asan Medical Center	Seoul, Songpa District	South Korea	Recruiting