Compare two versions of olaparib (BR2022 and BR2022-1) in people with BRCA-mutated advanced ovarian cancer
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
This will test whether two formulations of olaparib (BR2022 and BR2022-1) produce similar blood levels and have similar safety in adults with deleterious or suspected deleterious BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who are already taking olaparib.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 19 Years to 74 Years |
| Sex | Female |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seoul, Songpa District) |
| Trial ID | NCT07069335 on ClinicalTrials.gov |
What this trial studies
This is an open-label, randomized, crossover Phase 1 trial focused on pharmacokinetics and safety of two formulations of olaparib (BR2022 and BR2022-1). The study is conducted in two stages, with Stage 1 enrolling patients already on stable BR2022-1 therapy for more than three months and analyzing results before deciding whether to open Stage 2. Participants will receive olaparib 150 mg and have blood sampling and safety monitoring to compare drug exposure between formulations. The primary goal is to determine bioequivalence and document any differences in tolerability.
Who should consider this trial
Good fit: Adult females aged 19 to 74 with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been taking a stable dose of olaparib for more than three months are ideal candidates.
Not a fit: Patients who are not BRCA-mutated, who are pregnant or nursing, who have significant gastrointestinal conditions or prior surgeries that affect drug absorption, or who have known severe hypersensitivity to the drug ingredients are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could allow the alternative BR2022 formulation to be used interchangeably with BR2022-1, preserving treatment effects while potentially improving access or manufacturing options.
How similar studies have performed: Bioequivalence and pharmacokinetic comparisons of oral oncology formulations are common and often show comparable blood levels and safety when formulations are similar, though each formulation must be tested individually.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul, Songpa District
- Asan Medical Center — Seoul, Songpa District, South Korea (Recruiting)
Study contacts
- Study coordinator: Shinyoung Oh
- Email: syoh@boryung.co.kr
- Phone: +82 2-708-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.