A Bioequivalence Study to Evaluate Pharmacokinetics and Safety of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer

Boryung

Status and phase

Enrolling

Phase 1

Conditions

Ovarian Cancer

Treatments

Drug: Olaparib 150 MG

Study type

Interventional

Funder types

Industry

Identifiers

NCT07069335

BR-OLP-CT-101

Details and patient eligibility

About

This was a multicenter, open-label, randomized, crossover bioequivalence study to evaluate the pharmacokinetics and safety of BR2022 and BR2022-1 in Patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer.

Full description

This study will be conducted in two stages. Stage 1 enrolls patients who have been taking BR2022-1 as existing therapy, and results will be evaluated before deciding whether to proceed with the Stage 2 part of the study and enroll more patients.

Enrollment

24 estimated patients

Sex

Female

Ages

19 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Females aged 19 -74 at the time of consent
Those who voluntarily signed the informed consent to participate in this study
Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been taking stable doses of olaparib for more than 3 months before screening.

Exclusion criteria

Those who have a history of severe hypersensitivity to drugs that include the ingredients of the investigational product or have a history of clinically significant hypersensitivity reactions
Those who have gastrointestinal disorders (e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or have had surgeries (excluding appendectomy or hernia surgery) that may affect the absorption of the investigational products
Those who are pregnant, suspected of pregnancy, or nursing

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Sequence 1 (TR)

Experimental group

Description:

Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 1, subjects receive T (1d-7d) then R (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None

Treatment:

Drug: Olaparib 150 MG

Sequence 2 (RT)

Experimental group

Description:

Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 2, subjects receive R (1d-7d) then T (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None

Treatment:

Drug: Olaparib 150 MG

Trial contacts and locations

Central trial contact

Shinyoung Oh

Data sourced from clinicaltrials.gov

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