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

NCT07371104 | Recruiting Phase 1

• 1 other identifier: DW_DWZ2501101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ovarian Cancer; Cancer

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum plasma concentration of olaparib

  Day 8, Day 16 after dose administration

• AUCtau

  Area under the drug concentration-time curve of olapairb

  Day 8, Day 16 after dose administration

Study Arms (2)

Sequence A (Olaparib, RT)

EXPERIMENTAL

Subjects are randomized into two sequence groups. In Sequence A, subjects receive R then T. T: DWZ2501(Olaparib) R: DW202510(Olaparib)

Drug: DWZ2501 (Olaparib 150mg); Drug: DWC202510 (Olaparib 150mg)

Sequence B (Olaparib, TR)

EXPERIMENTAL

Subjects are randomized into two sequence groups. In Sequence B, subjects receive T then R. T: DWZ2501(Olaparib) R: DW202510(Olaparib)

Drug: DWZ2501 (Olaparib 150mg); Drug: DWC202510 (Olaparib 150mg)

Interventions

DWC202510 (Olaparib 150mg) DRUG

Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration

Sequence A (Olaparib, RT); Sequence B (Olaparib, TR)

DWZ2501 (Olaparib 150mg) DRUG

Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration

Sequence A (Olaparib, RT); Sequence B (Olaparib, TR)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Institutional Review Board of Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms; Ovarian Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-01

Locations

KR (1)