Actively Recruiting
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
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2025-07-16
24
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 19 to 74 years at consent
- Voluntarily signed informed consent
- Diagnosed with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Taking stable doses of olaparib for more than 3 months before screening
You will not qualify if you...
- History of severe hypersensitivity to any ingredient of the investigational products or clinically significant hypersensitivity reactions
- Gastrointestinal disorders or surgeries (except appendectomy or hernia surgery) that may affect drug absorption
- Pregnant, suspected of being pregnant, or currently nursing
AI-Screening
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Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, Songpa District, South Korea, 05505
Actively Recruiting
Research Team
S
Shinyoung Oh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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