Actively Recruiting

Phase 1
Age: 19Years +
FEMALE
NCT07371104

Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer

Led by Daewoong Pharmaceutical Co. LTD. · Updated on 2026-05-08

40

Participants Needed

1

Research Sites

44 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade Ovarian Cancer

CONDITIONS

Official Title

Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer

Who Can Participate

Age: 19Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female subjects aged 19 years or older at the time of obtaining written informed consent.
  • Patients with advanced high-grade ovarian cancer harboring a BRCA mutation.
  • Subjects who have been maintained on an olaparib dosing regimen of 300 mg orally twice daily for at least 10 consecutive days, or require a stable dose of olaparib 300 mg orally twice daily as judged by the principal investigator.
  • Subjects with an estimated life expectancy of at least 12 weeks.
  • Subjects with a body mass index (BMI) between 18.50 and 30.00 kg/m² at screening.
Not Eligible

You will not qualify if you...

  • Subjects with a history of hypersensitivity to the investigational product or any of its components.
  • Subjects with pneumonitis.
  • Subjects with myelodysplastic syndrome or acute myeloid leukemia.
  • Subjects with severe hepatic impairment (Child-Pugh class C).
  • Subjects with ongoing active infection or uncontrolled systemic disease.
  • Subjects with active hepatitis B, hepatitis C, HIV infection, or syphilis.
  • Subjects who received radiotherapy within 4 weeks prior to screening.
  • Subjects who received other anticancer therapies within 4 weeks prior to screening.
  • Subjects who underwent major surgery within 4 weeks prior to screening or have not adequately recovered from previous major surgery.
  • Subjects who experienced blood loss of approximately 350 mL or more within 12 weeks prior to screening.

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

Institutional Review Board of Seoul National University Hospital

Seoul, Jongno-gu, South Korea, 03080

Actively Recruiting

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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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