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

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

Trial Details

NCT ID
NCT07371104
Phase
PHASE1
Sponsor
Daewoong Pharmaceutical Co. LTD.
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • DWZ2501 (Olaparib 150mg)
  • DWC202510 (Olaparib 150mg)
Locations (sample)
  • Seoul, Jongno-gu, South Korea|37.566,126.9784

Key Eligibility Criteria

  • 1\. Female subjects aged 19 years or older at the time of obtaining written informed consent.
  • 2\. Patients with advanced high-grade ovarian cancer harboring a BRCA mutation. 3. Subjects who meet at least one of the following criteria:
  • Subjects who have been maintained on an olaparib dosing regimen of 300 mg (two 150 mg tablets) administered orally twice daily for at least 10 cons…
  • Subjects who, in the judgment of the principal investigator require a stable dose of olaparib 300 mg (two 150 mg tablets) administered orally twice…

For full eligibility, visit ClinicalTrials.gov.

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