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

NCT ID: NCT07069335

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2026-05-15

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence 1 (TR)

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

Group Type: EXPERIMENTAL

Olaparib 150 MG

Intervention Type: DRUG

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

Sequence 2 (RT)

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

Group Type: EXPERIMENTAL

Olaparib 150 MG

Intervention Type: DRUG

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

Interventions

Olaparib 150 MG

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

Intervention Type: DRUG

Other Intervention Names

BR2022

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan Medical Center

Seoul, Songpa District, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Shinyoung Oh

Role: CONTACT

syoh@boryung.co.kr

+82 2-708-8000

Facility Contacts

Role: primary

01034379425

Other Identifiers

BR-OLP-CT-101

Identifier Type: -

Identifier Source: org_study_id