Clinical trial NCT05081765: The Effect of Glucose Level and Diabetes Mellitus on Ctrough of Olaparib
Official title: The Effect of Glucose Level and Diabetes Mellitus on the Plasma Minimum Steady-state Concentration Ctrough of Olaparib in Patients With Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovary Cancer
Keywords: olaparib
blood-level testing
C through
diabetes melitus
hyperglycemia
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Poznan University Hospital of Lord's Transfiguration
First posted: 2021-10-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects of the research are patients with ovarian cancer who received olaparib as a maintance therapy after platin basen chemotherapy

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: correlation between glucose level and C through.olaparib in the blood of the patients with ovarian cancer
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: University od Medical Sciences
Study officials:
affiliation: University of Medical Sciences Poznań, Poland
name: Joanna J Stanisławiak - Rudowicz
role: PRINCIPAL_INVESTIGATOR
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