The Effect of Glucose Level and Diabetes Mellitus on Ctrough of Olaparib

Poznan University of Medical Sciences (PUMS)

Status: Unknown

Conditions: Ovary Cancer

Treatments: Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.); Device: Lynparza

Study type: Observational

Funder types: Other

Identifiers

NCT05081765

697/20

Details and patient eligibility

About

Monitored therapy of olaparib concentrations in the blood of diabetic population probably will assess the need for individual dosing of the drug.

The project concerns on the monitored therapy of olaparib in a population of patients with DM, hyperglycemia and normal glucose level.

Currently, there are no studies assessing the effect of comorbidities and of the administered drugs on the pharmacokinetics of olaparib.

Full description

The research is conducted at the Poznan University of Medical Sciences, and the Poznan, Poland with the approval from the Bioethics Committee, University of Medical Sciences, Poznan, Poland (697/20). The subjects of the research: the C through of olaparib in the patients with ovarian cancer who received olaparib The patients included in the study if they met the following criteria: treatment with olaparib above four days, age >18 years; no history of allergy to olaparib. The chief criteria for exclusion included allergy to olaparib, age under 18 years, status of the patient which do not allowed the patient to continue the study.

Administration and blood sampling The patients with an ovarian cancer treated with olaparib (tablets in dose 300mg/12h, 250mg/12h, 200 mg/12h or capsules 400mg/12h, 200mg/12h, 100 mg/12h).

Blood samples (2 mL) collected at steady state before morning drug administration. The blood samples transferred into heparinised tubes and centrifuged at 2880 g for 10 min at 4 °C. Next the plasma transferred to propylene tubes and stored at - 20 °C until analysis.

Assays The concentrations of olaparib in plasma assayed using the high-performance liquid chromatography (HPLC) method with ultraviolet (UV) detection. The method validated according to European Medicines Agency guideline. The method validation confirmed good precision (CV% <15%), accuracy (92.3-115.0%) and linearity (r=0.9994) in the range of 100-4000 ng/mL.

The severity of olaparib adverse effects assessed by CTCAE (Common Terminology Criteria for Adverse Events) v.5.0 scale.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ovarian cancer patients treated with olaparib above than 4 days
• patient who gave permission to take part in the trial
• age >18 years
• no history of allergy to olaparib

Exclusion criteria

• allergy to olaparib,
• age under 18 years,
• status of the patient which do not allowed the patient to continue the study.

Trial design

40 participants in 3 patient groups

Patients with diabetes mellitus

Description:

olaparib 2 x 300mg /24h tablets = olaparib 2 x 400mg/24 olaparib 2 x 250mg/24h tablets = olaparib 2 x 200mg/24h olaparib 2 x 200mg/24h tablets = olaparib 2 x 100mg/24h

Treatment:

Device: Lynparza

Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)

Patients with hyperglycemia,

Description:

olaparib 2 x 300mg /24h tablets = olaparib 2 x 400mg/24 olaparib 2 x 250mg/24h tablets = olaparib 2 x 200mg/24h olaparib 2 x 200mg/24h tablets = olaparib 2 x 100mg/24h

Treatment:

Device: Lynparza

Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)

Patient with normal glucose level

Description:

olaparib 2 x 300mg /24h tablets = olaparib 2 x 400mg/24 olaparib 2 x 250mg/24h tablets = olaparib 2 x 200mg/24h olaparib 2 x 200mg/24h tablets = olaparib 2 x 100mg/24h

Treatment:

Device: Lynparza

Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)