Clinical trial · Observational
The Effect of Glucose Level and Diabetes Mellitus on Ctrough of Olaparib
The Effect of Glucose Level and Diabetes Mellitus on the Plasma Minimum Steady-state Concentration Ctrough of Olaparib in Patients With Ovarian Cancer
NCT05081765CI-TRIAL-00054512unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovary Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lynparza | Device | — | UNRESOLVED |
| Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.) | Drug | Olaparib | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- 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
- interventionNames
- Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)
- Device: Lynparza
- label
- 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
- interventionNames
- Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)
- Device: Lynparza
- label
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (13)
- BACKGROUNDDebska S, Kubicka J, Czyzykowski R, Habib M, Potemski P. [PARP inhibitors--theoretical basis and clinical application]. Postepy Hig Med Dosw (Online). 2012 May 30;66:311-21. doi: 10.5604/17322693.999033. Polish. PMID 22706117
- BACKGROUNDWisnik E, Ryksa M, Koter-Michalak M. [PARP1 inhibitors: contemporary attempts at their use in anticancer therapy and future perspective]. Postepy Hig Med Dosw (Online). 2016 Apr 13;70:280-94. doi: 10.5604/17322693.1199303. Polish. PMID 27117104
- BACKGROUNDLedermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31. PMID 24882434
- BACKGROUNDFriedlander M, Banerjee S, Mileshkin L, Scott C, Shannon C, Goh J. Practical guidance on the use of olaparib capsules as maintenance therapy for women with BRCA mutations and platinum-sensitive recurrent ovarian cancer. Asia Pac J Clin Oncol. 2016 Dec;12(4):323-331. doi: 10.1111/ajco.12636. PMID 27917619
- BACKGROUNDSzalek E, Karbownik A, Sobanska K, Grabowski T, Polom W, Lewandowska M, Wolc A, Matuszewski M, Grzeskowiak E. The pharmacokinetics and hypoglycaemic effect of sunitinib in the diabetic rabbits. Pharmacol Rep. 2014 Oct;66(5):892-6. doi: 10.1016/j.pharep.2014.05.011. Epub 2014 Jun 6. PMID 25149997
- BACKGROUNDKarbownik A, Szalek E, Sobanska K, Grabowski T, Wolc A, Grzeskowiak E. The alteration of pharmacokinetics of erlotinib and OSI420 in type 1 diabetic rabbits. Pharmacol Rep. 2016 Oct;68(5):964-8. doi: 10.1016/j.pharep.2016.04.015. Epub 2016 May 6. PMID 27372922