Dried Blood SPOT Analysis of Everolimus in Cancer Patients (SPOT-study)

Breast Cancer Clinical Trial

— SPOT  

Official title:

Dried Blood SPOT Analysis of Everolimus in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809404
• Other study ID #: MOMAM15-SPOT
• Status: Completed
• Phase: N/A
• First received: June 1, 2016
• Last updated: October 13, 2017
• Start date: June 2015
• Est. completion date: January 2017

Study information

• Verified date: May 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Everolimus shows a large interpatient variability with fixed dose administration. These very different exposure levels between individuals can result in supratherapeutic or subtherapeutic exposure levels and consequently in over- or undertreatment, respectively. Dose individualization based on the measured drug concentration could theoretically result in less toxicity and more efficacy.

Nowadays everolimus exposure is determined by everolimus concentration in whole blood. Therefore, a vena puncture is always necessary. This is invasive and requires patients to come to the hospital. It would be convenient for patients to have their everolimus blood concentration determined by dried blood spot (DBS) analysis. With DBS only a single drop of blood from the finger is necessary, which can be done at home and sent by regular mail for analysis. Previous studies have shown the feasibility of this approach. In patients with cancer treated with everolimus 10mg once daily, the correlation between everolimus DBS concentrations and whole blood concentration is yet unknown. Therefore, the investigators want to determine the everolimus concentration collected with DBS from a finger prick with everolimus concentration from whole blood and everolimus concentration collected with DBS from whole blood.

In addition, possibly a relatively high everolimus concentration in saliva could be correlated with the incidence and severity of oral mucositis. Determination of drug concentration in saliva has also been proven to be feasible before.

Therefore, in this study the investigators want to determine whether the everolimus concentration in saliva correlates with the incidence of oral mucositis and how everolimus concentration in saliva correlates with everolimus concentration in whole blood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients currently treated with everolimus for any type of cancer

• Patients from whom it is possible to collect blood samples

• At least 18 years of age

• Able and willing to sign the Informed Consent Form prior to study assessments.

Exclusion Criteria:

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Everolimus

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation everolimus concentration DBS with whole blood	Correlation between trough everolimus concentration from DBS analysis collected with finger prick with trough everolimus concentration in whole blood, measured at any time during everolimus treatment	Up to 2 years
Secondary	Correlation everolimus concentration whole blood with saliva	Correlation between trough everolimus concentration from whole blood with trough everolimus concentration in saliva, measured at any time during everolimus treatment	Up to 2 years