RecruitingPhase 1

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

South Korea40 participantsStarted 2026-04-22

Plain-language summary

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

Who can participate

Age range19 Years

SexFEMALE

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Inclusion 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 consecutive days.
✓. Subjects who, in the judgment of the principal investigator require a stable dose of olaparib 300 mg (two 150 mg tablets) administered orally twice daily 4. Subjects with an estimated life expectancy of at least 12 weeks. 5. Subjects with a body mass index(BMI) between 18.50 and 30.00 kg/m² at screening.

Exclusion criteria

✕. Subjects with a history of hypersensitivity to the investigational product or any of its components.
✕. Subjects with any of the following concomitant conditions:
✕. Radiotherapy within 4 weeks prior to screening.
✕. Other anticancer therapies within 4 weeks prior to screening. 4. Subjects who have undergone major surgery within 4 weeks prior to screening or who have not adequately recovered from a previous major surgery.

What they're measuring

Cmax

Timeframe: Day 8, Day 16 after dose administration

AUCtau

Timeframe: Day 8, Day 16 after dose administration

Trial details

NCT IDNCT07371104

SponsorDaewoong Pharmaceutical Co. LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

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