Comparing two olaparib formulations (DWZ2501 vs DWC202510) for 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

This trial tests whether DWZ2501 and DWC202510 (both olaparib 150 mg) produce the same blood levels and safety in patients with advanced BRCA‑mutated high‑grade ovarian cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 19 Years and up
• Sex: Female
• Sponsor: Daewoong Pharmaceutical Co. LTD. (industry)
• Locations: 1 site (Seoul, Jongno-gu)
• Trial ID: NCT07371104 on ClinicalTrials.gov

What this trial studies

This Phase 1, multicenter, open‑label, randomized, multi‑dose, two‑sequence, two‑period crossover study compares the pharmacokinetics and safety of DWZ2501 and DWC202510, each containing olaparib 150 mg. Eligible patients are those with advanced high‑grade ovarian cancer and a BRCA mutation who are maintained on or require a stable olaparib dose of 300 mg twice daily and meet BMI and life‑expectancy criteria. Each participant receives both formulations in different periods so that drug exposure and adverse events can be directly compared within the same person. Pharmacokinetic sampling and safety monitoring are performed after dosing to determine whether the two formulations are bioequivalent.

Who should consider this trial

Good fit: Ideal candidates are women aged 19 or older with advanced high‑grade ovarian cancer and a BRCA mutation who are on or need a stable olaparib regimen of 300 mg twice daily, have a BMI of 18.5–30 kg/m², and an estimated life expectancy of at least 12 weeks.

Not a fit: Patients with known hypersensitivity to olaparib or with certain serious conditions such as pneumonitis, myelodysplastic syndrome, or acute myeloid leukemia are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could confirm an alternative formulation of olaparib that provides equivalent exposure and safety, potentially improving access or supply options for patients.

How similar studies have performed: Olaparib is an established therapy for BRCA‑mutated ovarian cancer and bioequivalence trials comparing different formulations of approved drugs are commonly used and have been successful in confirming similar exposure and safety.

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:

1. 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.
2. 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:

1. Subjects with a history of hypersensitivity to the investigational product or any of its components.
2. 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:

1. Radiotherapy within 4 weeks prior to screening.
2. 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.

Where this trial is running

Seoul, Jongno-gu

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

Conditions: Cancer, Ovarian Cancer