RecruitingPhase 1NCT07371104

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


Sponsor

Daewoong Pharmaceutical Co. LTD.

Enrollment

40 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new formulation of olaparib (a PARP inhibitor used to treat ovarian cancer) called DWZ2501 has the same effectiveness and is absorbed the same way in the body as the standard olaparib tablets in women with advanced ovarian cancer who carry a BRCA gene mutation. **You may be eligible if...** - You are female, aged 19 or older - You have advanced high-grade ovarian cancer with a BRCA mutation - You are currently taking olaparib 300 mg (two 150 mg tablets) twice daily, or your doctor determines this dose is appropriate for you - Your life expectancy is at least 12 weeks - Your body mass index (BMI) is between 18.5 and 30 **You may NOT be eligible if...** - You have had an allergic reaction to olaparib or similar drugs - You have pneumonitis (lung inflammation), a blood cancer, or severe liver disease - You have an active infection or HIV, hepatitis B, hepatitis C, or syphilis - You have received chemotherapy or radiation therapy within the past 4 weeks - You have had major surgery in the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDWZ2501 (Olaparib 150mg)

Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration

DRUGDWC202510 (Olaparib 150mg)

Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration


Locations(1)

Institutional Review Board of Seoul National University Hospital

Seoul, Jongno-gu, South Korea

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NCT07371104


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