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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Glucose Level and Diabetes Mellitus on the Plasma Minimum Steady-state Concentration Ctrough of Olaparib in Patients With Ovarian Cancer

Conditions
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Ovary Cancer

Intervention / Treatment
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* Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)
* Device: Lynparza


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with diabetes mellitus<br>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 | Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)<br>* correlation between C through and taken drug<br>* Other names: olaparib;Device: Lynparza<br>* correlation between C through and taken drug<br>* Other names: olaparib;|
| Patients with hyperglycemia,<br>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 | Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)<br>* correlation between C through and taken drug<br>* Other names: olaparib;Device: Lynparza<br>* correlation between C through and taken drug<br>* Other names: olaparib;|
| Patient with normal glucose level<br>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 | Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)<br>* correlation between C through and taken drug<br>* Other names: olaparib;Device: Lynparza<br>* correlation between C through and taken drug<br>* Other names: olaparib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between glucose level and C through.olaparib in the blood of the patients with ovarian cancer | There is idea to check the correlation of C through of the olaparib taken by the patients with diabetes melitus and ovarian cancer and the correlation of C through and glucose of the patients with hyperglycemia diagnosed during olaparib treatment | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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olaparib, blood-level testing, C through, diabetes melitus, hyperglycemia