Comparing two olaparib formulations (DWZ2501 vs DWC202510) for advanced BRCA‑mutated high‑grade ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institutional Review Board of Seoul National University Hospital
  Seoul, Jongno-gu, South Korea Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.