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

NCT05081765 | Unknown DMC FDA Drug FDA Device

• 1 other identifier: 697/20
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovary Cancer

Keywords

olaparib; blood-level testing; C through; diabetes melitus; hyperglycemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Patients with diabetes mellitus

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.); Device: Lynparza

Patients with hyperglycemia,

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.); Device: Lynparza

Patient with normal glucose level

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.); Device: Lynparza

Interventions

Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.) DRUG

correlation between C through and taken drug

Also known as: olaparib

Patient with normal glucose level; Patients with diabetes mellitus; Patients with hyperglycemia,

Lynparza DEVICE

correlation between C through and taken drug

Also known as: olaparib

Patient with normal glucose level; Patients with diabetes mellitus; Patients with hyperglycemia,

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead
• Poznan University Hospital of Lord's Transfiguration: collaborator

Study Sites (1)

University od Medical Sciences

Poznan, Poland

RECRUITING

Related Publications (13)

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  PMID: 24882434 BACKGROUND

• Friedlander 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 BACKGROUND

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  PMID: 25149997 BACKGROUND

• Karbownik 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 BACKGROUND

• Dostalek M, Court MH, Yan B, Akhlaghi F. Significantly reduced cytochrome P450 3A4 expression and activity in liver from humans with diabetes mellitus. Br J Pharmacol. 2011 Jul;163(5):937-47. doi: 10.1111/j.1476-5381.2011.01270.x.

  PMID: 21323901 BACKGROUND

• Dostalek M, Akhlaghi F, Puzanovova M. Effect of diabetes mellitus on pharmacokinetic and pharmacodynamic properties of drugs. Clin Pharmacokinet. 2012 Aug 1;51(8):481-99. doi: 10.2165/11631900-000000000-00000.

  PMID: 22668340 BACKGROUND

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  BACKGROUND

• Porazka J, Szalek E, Polom W, Czajkowski M, Grabowski T, Matuszewski M, Grzeskowiak E. Influence of Obesity and Type 2 Diabetes Mellitus on the Pharmacokinetics of Tramadol After Single Oral Dose Administration. Eur J Drug Metab Pharmacokinet. 2019 Aug;44(4):579-584. doi: 10.1007/s13318-019-00543-1.

  PMID: 30778911 BACKGROUND

• Stachowiak A, Szalek E, Karbownik A, Lojko A, Porazka J, Przewozna I, Grabowski T, Wolc A, Grzeskowiak E. The Influence of Diabetes Mellitus on Glucuronidation and Sulphation of Paracetamol in Patients with Febrile Neutropenia. Eur J Drug Metab Pharmacokinet. 2019 Apr;44(2):289-294. doi: 10.1007/s13318-018-0508-4.

  PMID: 30187443 BACKGROUND

• Karbownik A, Szalek E, Sobanska K, Klupczynska A, Plewa S, Grabowski T, Wolc A, Moch M, Kokot ZJ, Grzeskowiak E. A pharmacokinetic study on lapatinib in type 2 diabetic rats. Pharmacol Rep. 2018 Apr;70(2):191-195. doi: 10.1016/j.pharep.2017.09.003. Epub 2017 Sep 18.

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  PMID: 32016844 BACKGROUND

Related Links

• Summary of product characteristic
• Onkol Prakt Klin Edu 2018;4(3):167-178.

Biospecimen

Retention: SAMPLES WITH DNA

The probe with blood taken to check the C through of olaparib

MeSH Terms

Conditions

Ovarian Neoplasms; Hyperglycemia

Interventions

olaparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joanna J Stanisławiak - Rudowicz

  University of Medical Sciences Poznań, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna i Stanislawiak-Rudowicz, MD, PhD

CONTACT

0048605781967; stanisl@interia.pl

Edyta Szałek, Prof

CONTACT

0048604773994; szalekedyta@wp.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Doctor

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 18, 2021
• Study Start: September 20, 2021
• Primary Completion: October 15, 2022
• Study Completion: December 31, 2022
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

PL (1)