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

Daewoong Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Cancer; Ovarian Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07371104

DW_DWZ2501101

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sequence A (Olaparib, RT)

Experimental group

Description:

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

Treatment:

Drug: DWZ2501 (Olaparib 150mg)

Drug: DWC202510 (Olaparib 150mg)

Sequence B (Olaparib, TR)

Experimental group

Description:

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

Treatment:

Drug: DWZ2501 (Olaparib 150mg)

Drug: DWC202510 (Olaparib 150mg)