Compare two versions of olaparib (BR2022 and BR2022-1) in people with BRCA-mutated advanced ovarian cancer
Official 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
Run by Boryung Pharmaceutical Co., Ltd · NCT07069335 · Data updated 2026-11-12
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 |
| Ages | 19 Years to 74 Years |
| Sex | Women only |
| Enrollment | 24 (estimated) |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seoul, Songpa District) |
| Status | Recruiting |
| Started | June 17, 2025 |
| Main results expected | May 15, 2026 |
| Study ends | May 15, 2026 |
| Registry record updated | July 16, 2025 |
| Trial ID | NCT07069335 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.