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

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

Recruiting
19 years and older
Female
Phase 1

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Overview

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

Eligibility

Inclusion Criteria:

  • Participant aged 18 years old and over
  • Participant for whom a total hysterectomy with or without adnexectomy for the treatment of a benign pathology must be scheduled
  • Participant with no contraindication to being operated on by one of the three approaches under study (conventional laparoscopy, V-Notes, robot-assisted laparoscopy)
  • Patient eligible for outpatient treatment
  • Participant affiliated or beneficiary of a social security regimen
  • Participant having been informed and having given her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research)

Exclusion Criteria:

  • Participant with endometriosis with procedure associated with hysterectomy (digestive procedure, extended adhesiolysis, or other procedure)
  • Participant whose physical and/or psychological health is severely impaired, which according to the investigator may affect the participant's understanding and compliance with the study
  • Participant in another research
  • Participant in a period of exclusion from another research still in progress at the time of inclusion
  • Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Patient hospitalized without consent

Study details
    Cancer
    Ovarian Cancer

NCT07371104

Daewoong Pharmaceutical Co. LTD.

13 May 2026

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FAQs

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