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

Recruiting now · Phase 1

Conditions studied: Cancer, Ovarian Cancer

In brief

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

Key facts

Study ID

NCT07371104

Run by

Daewoong Pharmaceutical Co. LTD.

People needed

40

Starts

2026-04-22

Expected to finish

2027-03-01

Last updated by the study team

2026-05-08

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female subjects aged 19 years or older at the time of obtaining written informed consent.
• 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 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.

You may not qualify if…

• Subjects with a history of hypersensitivity to the investigational product or any of its components.
• Subjects with any of the following concomitant conditions:
• (1) Pneumonitis (2) Myelodysplastic syndrome or acute myeloid leukemia (3) Severe hepatic impairment(Child-Pugh class C). (4) Ongoing active infection or uncontrolled systemic disease (5) Active hepatitis B, hepatitis C, human immunodeficiency virus(HIV) infection, or syphilis.
• Subjects who have received the following drug and non-drug treatments at screening:
• 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.
• Subjects who have experienced blood loss of approximately 350 mL or more within 12 weeks prior to screening.

Where it is running

• Institutional Review Board of Seoul National University Hospital — Seoul, Jongno-gu, South Korea (enrolling)

Full record on ClinicalTrials.gov

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