Ovarian Cancer
Conditions
Keywords
BRCA-mutated, Ovarian Cancer, BR2022
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.
Interventions
DRUGOlaparib 150 MG
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic variable - Cmax | From Day 6 to Day 7 after dose administration | Maximum plasma concentration of BR2022 and BR2022-1 |
| Pharmacokinetic variable - AUCtau | From Day 6 to Day 7 after dose administration | Area under the drug concentration-time curve over the time interval from Day 6 to Day 7 after dose administration |
Countries
South Korea
Contacts
Primary ContactShinyoung Oh
Outcome results
None listed