Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

Qilu Pharmaceutical

Status: Completed

Conditions: Neoplasms

Treatments: Drug: The test olaparib tablet (T); Drug: The reference olaparib tablet (R)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05860530

QL-YK3-052-001

Details and patient eligibility

About

This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Had BMI 18.0 kg/m^2, and weight ≥ 50 kg for male, or ≥ 45 kg for female
• Patients who were on olaparib treatment, had epithelial ovarian, fallopian tube, or primary peritoneal cancer, or were eligible for olaparib treatment judged investigators
• Had ECOG performance status 0-1
• Had life expectancy >12 weeks
• Had Adequate organ function or clinically irrelevant abnormal result
• Agreed to use adequate contraception from 14 days before treatment initiation to 6 months after last dose

Exclusion criteria

• Allergic to any component of study drugs
• Had central nervous system metastases (stable and asymptomatic metastases were acceptable)
• Had other malignancy within 5 years
• Had disease affecting swallow or absorption
• Received major surgery within 1 month before study drug administration
• Had major disease
• Had continuous grade 3-4 adverse event
• Had drug abuse
• Had (suspected) pneumonitis
• Participated in other clinical trial of drug or device within 1 month
• Lost or donated blood > 200 mL or received blood transfusion within 1 month
• With average alcohol consumption > 14 units/week or cigarette consumption > 20/day within 1 month
• Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
• Received strong or moderate CYP3A inducer or inhibitor within 3 half-lives of the drug
• Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine
• For female, pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Test-reference

Other group

Description:

Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days.

Treatment:

Drug: The reference olaparib tablet (R)

Drug: The test olaparib tablet (T)

Reference-test

Other group

Description:

Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days.

Treatment:

Drug: The reference olaparib tablet (R)

Drug: The test olaparib tablet (T)