Asan Medical Center
Seoul, Songpa District, 05505, South Korea
Location status: Recruiting
Location contact
CONTACT
NCT Number: NCT07069335
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.
Interested in participating?
Request Info19 year–74 year
Female
Interventional
Phase 1
Seoul, Songpa District, 05505, South Korea
Location status: Recruiting
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
Other names: BR2022
Time frame: From Day 6 to Day 7 after dose administration
Maximum plasma concentration of BR2022 and BR2022-1
Time frame: 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
Contact information is provided by the study sponsor or research team.
Boryung Pharmaceutical Co., Ltd
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07539844
Adnexal Diseases, Endocrine Gland Neoplasms
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
View Trial DetailsNCT07059845
Adnexal Diseases, Endocrine Gland Neoplasms
La Jolla, California, United States
View Trial DetailsNCT04657068
Acinar Cell Carcinoma, Adenocarcinoma
Birmingham, Alabama, United States
View Trial DetailsNCT03877796
Adnexal Diseases, Endocrine Gland Neoplasms
Tampa, Florida, United States
View Trial Details