NCT07069335

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_1 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

July 7, 2025

Last Update Submit

July 7, 2025

Conditions

Ovarian Cancer

Keywords

BRCA-mutatedOvarian CancerBR2022

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic variable - Cmax

    Maximum plasma concentration of BR2022 and BR2022-1

    From Day 6 to Day 7 after dose administration

  • Pharmacokinetic variable - AUCtau

    Area under the drug concentration-time curve over the time interval from Day 6 to Day 7 after dose administration

    From Day 6 to Day 7 after dose administration

Study Arms (2)

Sequence 1 (TR)

EXPERIMENTAL

Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 1, subjects receive T (1d-7d) then R (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None

Drug: Olaparib 150 MG

Sequence 2 (RT)

EXPERIMENTAL

Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 2, subjects receive R (1d-7d) then T (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None

Drug: Olaparib 150 MG

Interventions

Olaparib 150 MGDRUG

Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration

Also known as: BR2022
Sequence 1 (TR)Sequence 2 (RT)

Eligibility Criteria

Age19 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Those who are pregnant, suspected of pregnancy, or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa District, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Shinyoung Oh

CONTACT

+82 2-708-8000syoh@boryung.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

June 17, 2025

Primary Completion

May 15, 2026

Study Completion

May 15, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)