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OncoMatch/Clinical Trials/NCT07371104

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

Is NCT07371104 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including DWZ2501 (Olaparib 150mg) and DWC202510 (Olaparib 150mg) for cancer.

Phase 1RecruitingDaewoong Pharmaceutical Co. LTD.NCT07371104Data as of May 2026

Treatment: DWZ2501 (Olaparib 150mg) · DWC202510 (Olaparib 150mg)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

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Biomarker criteria

Required: BRCA1 mutation

Required: BRCA2 mutation

Disease stage

Grade: high-grade

advanced high-grade ovarian cancer

Prior therapy

Must have received: PARP inhibitor (olaparib) — maintenance

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

Must have received: PARP inhibitor (olaparib) — maintenance

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

Cannot have received: radiation therapy

Radiotherapy within 4 weeks prior to screening

Cannot have received: anticancer therapy

Other anticancer therapies within 4 weeks prior to screening

Lab requirements

Liver function

No severe hepatic impairment (Child-Pugh class C)

Severe hepatic impairment (Child-Pugh class C) [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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