Actively Recruiting

Phase 1
Age: 19Years - 74Years
FEMALE
NCT07069335

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

Age: 19Years - 74Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Asan Medical Center

Seoul, Songpa District, South Korea, 05505

Actively Recruiting

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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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