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
Daewoong Pharmaceutical Co. LTD.
40 participants
Feb 20, 2026
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
Inclusion Criteria4
- \. 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.
Exclusion Criteria7
- 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.
Interventions
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07371104