Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DWZ2501 (Olaparib 150mg), DWC202510 (Olaparib 150mg).
- Who it may be relevant to
- Registry conditions: Cancer, Ovarian Cancer. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug DWZ2501 (Olaparib 150mg)
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration - Drug DWC202510 (Olaparib 150mg)
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
Primary outcome measures
- Cmax [Time frame: Day 8, Day 16 after dose administration]
- AUCtau [Time frame: Day 8, Day 16 after dose administration]
Eligibility criteria
Inclusion criteria
1\. Female subjects aged 19 years or older at the time of obtaining written informed consent.
2\. 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 criteria
- 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.
3\. 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.
5\. Subjects who have experienced blood loss of approximately 350 mL or more within 12 weeks prior to screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Institutional Review Board of Seoul National University Hospital — Seoul
Identifiers
NCT: NCT07371104 · DW_DWZ2501101