The clinical validation of a DBS method for the quantification of ribociclib using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To develop and validate a dried blood spot (DBS) method for determination of
ribociclib.
Secondary outcome
To characterize the pharmacokinetics of ribociclib.
Background summary
TDM is the measurement of drug concentrations in blood to determine
pharmacokinetic parameters, in order to optimize individual dosage regimes.
Dried Blood Spot (DBS) sampling by finger prick for the use of TDM has become
more common over the years, including the field of medical oncology. DBS
sampling is minimally invasive and is a promising patient-friendly alternative
to venous sampling, since the technique can be performed by patients at their
homes and the samples can be sent to a laboratory by regular mail for analysis.
Ribociclib is a selective inhibitor of cyclin-dependent kinases 4/6 and results
in combination with letrozole in improved progression-free survival versus
letrozole alone in patients with hormone positive advanced breast cancer.
Ribociclib is used at a fixed oral dose of 600 mg once daily (3 weeks on / 1
week off), which may be reduced in case of toxicity. Currently we are exploring
the need for dose individualization based on therapeutic drug monitoring as
part of nationwide SONIA trial (NL62197.031.17). When a DBS method is validated
successfully, we will be able to monitor the ribociclib concentration less
invasively at an optimally timed time-point. Therefore, the objective of this
study is the development and analytically validate a DBS method for ribociclib.
Study objective
The clinical validation of a DBS method for the quantification of ribociclib
using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Study design
Cross-sectional observational study.
Study burden and risks
Participants will undergo at a maximum of four hospital visits a finger prick
(<50 uL) and a 4.5 mL blood sample taken by a venipuncture. These interventions
may cause mild pain or local irritation. All samples will be taken during
regular hospital visits. Blood samples will be taken during standard blood
control to minimize the number of venipunctures.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. Age * 18 years;
2. Able to understand the written information and able to give informed consent;
3. Treated with ribociclib;
4. Able and willing to undergo a finger prick for dried blood spot sampling.
Exclusion criteria
Unable to draw blood for study purposes.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70792.078.19 |