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

October 13, 2021 updated by: Stanisławiak-Rudowicz Joanna, Poznan University of Medical Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Joanna i Stanislawiak-Rudowicz, MD, PhD
  • Phone Number: 0048605781967
  • Email: stanisl@interia.pl

Study Contact Backup

Study Locations

  • Poland
      • Poznań, Poland
        • Recruiting
        • University od Medical Sciences
        • Contact:
          • Joanna Stanislawiak-Rudowicz, MD,PhD
          • Phone Number: 0048605781967
          • Email: stanisl@interia.pl
        • Principal Investigator:
          • Joanna Stanislawiak-Rudowicz, MD, PhD
        • Sub-Investigator:
          • Edyta Szalek, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.)
correlation between C through and taken drug
Other Names:
  • olaparib
Device: Lynparza
correlation between C through and taken drug
Other Names:
  • olaparib
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.)
correlation between C through and taken drug
Other Names:
  • olaparib
Device: Lynparza
correlation between C through and taken drug
Other Names:
  • olaparib
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.)
correlation between C through and taken drug
Other Names:
  • olaparib
Device: Lynparza
correlation between C through and taken drug
Other Names:
  • olaparib

What is the study measuring?

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
Time Frame: 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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Collaborators

Poznan University Hospital of Lord's Transfiguration

Investigators

  • Principal Investigator: Joanna J Stanisławiak - Rudowicz, University of Medical Sciences Poznań, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2021

Primary Completion (ANTICIPATED)

October 15, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

October 1, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (ACTUAL)

October 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 697/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To check C through of olaparib and morphology, Alat, Aspat and GFR and glucose level

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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