NCT07069335RecruitingPhase 1
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
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
Source: ClinicalTrials.gov · Last updated 16 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- 17 Jun 2025
- Primary completion date
- 15 May 2026
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Diseases
- Ovarian cancer
- NCT number
- NCT07069335
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 17 Jun 2025 to the primary completion date, 15 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other
- Those who are pregnant, suspected of pregnancy, or nursing
Who the study is looking for
- Females aged 19 -74 at the time of consent
- Those who voluntarily signed the informed consent to participate in this study
- 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.
Age in the registry: 19 years to 74 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.