Ovary Cancer
Conditions
Keywords
olaparib, blood-level testing, C through, diabetes melitus, hyperglycemia
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.
Interventions
DRUGLynparza® (AstraZeneca Pharma Poland Sp. z o.o.)
correlation between C through and taken drug
DEVICELynparza
correlation between C through and taken drug
Sponsors
Poznan University Hospital of Lord's Transfiguration
Poznan University of Medical Sciences
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| correlation between glucose level and C through.olaparib in the blood of the patients with ovarian cancer | through study completion, an average of 1 year | 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 |
Countries
Poland
Contacts
Primary ContactJoanna i Stanislawiak-Rudowicz, MD, PhD
Backup ContactEdyta Szałek, Prof
Outcome results
None listed