Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545292
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Microsampling to Facilitate Drug Monitoring of Oncolytics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MSTDM
Brief Summary:
The aim of the study is to perform a clinical validation of the analytical method for dried blood spot microsampling of cabozantinib pazopanib sunitinib Lenvatinib nivolumab ipilimumab pembrolizumab atezolizumab or bevacizumab The secondary objective is to test the feasibility of home monitoring microsampling TDM of cabozantinib pazopanib sunitinib Lenvatinib nivolumab ipilimumab pembrolizumab atezolizumab or bevacizumab in oncology patients
Detailed Description:
Rationale Oral targeted anti-cancer drugs are a relatively novel group of drugs with a complex pharmacological profile Due to the high pharmacokinetic interpatient variability and advised fixed dose a wide variability in blood concentrations is seen in patients Chances for individuals patients are high to be either underdoses 30 of patients or overdoses 15 which can lead to either decreased efficacy or severe side effects In recent years the development of monoclonal antibodies has changed the standard of care for treatment of many cancer types While a small group of patients can have persisting efficacy costs of monoclonal antibodies are extremely high While no predictive biomarker has been established to predict response before treatment recent research has shown clearance of immune checkpoint inhibitors varies over time and predicts early response Therapeutic drug monitoring TDM based on measured drug levels is a well-established method for personalized dosing of drugs It has become part of standard of care when treating patients with oral antineoplastic agents Currently venous blood sampling is performed at the hospital Home sampling of oral oncolytics by taking capillary blood samples by patients themselves provides many benefits It could reduce the burden of extra blood sampling at the hospital and the need for additional phone calls afterwards for dose guiding As of today microsampling of immune checkpoint inhibitors is exploratory Additionally home sampling offers the possibility to collect multiple samples over a dose interval and to base dose recommendation on AUC rather than only on trough concentrations Ctrough To achieve this goal clinical validation and implementations studies for microsampling are warranted
Objective The primary objective is to perform a clinical validation of the analytical method for dried blood spot microsampling of cabozantinib pazopanib sunitinib Lenvatinib nivolumab ipilimumab pembrolizumab atezolizumab or bevacizumab The secondary objective is to test the feasibility of home monitoring microsampling TDM of cabozantinib pazopanib sunitinib Lenvatinib nivolumab ipilimumab pembrolizumab atezolizumab or bevacizumab in oncology patients
Study design A single center prospective clinical validation study Study population Patients treated in the LUMC with cabozantinib pazopanib sunitinib lenvatinib nivolumab ipilimumab pembrolizumab atezolizumab or bevacizumab
Intervention if applicable Patients who use an oral oncolytic will be asked to provide twelve microsamples obtained by finger prick eight dried blood spots DBS and four wet blood samples in microtainer EDTA and four paired whole blood WB samples obtained by venapuncture The paired samples have to be obtained within 5 minutes of each other Sampling will take place before the ingestion of the oral oncolytic through concentration Cthrough and every hour for three hours after drug administration C1 C2 and C3
Patients who receive immune checkpoints inhibitors will be asked to provide eight microsamples obtained by finger prick six DBS and two wet blood in microtainer EDTA and two paired WB samples obtained by venapuncture Sampling will take place just before infusion Ctrough and 15 minutes after the end of the infusion Cinfusion025 of the next cycle of immune checkpoint inhibitors Microsampling collection will be performed using two different sampling devices HemaXis DB 10 and Mitra Clamshell Patients will be assisted by a research nurse with the sampling of the first spot and the sampling of the remaining spots will be performed by the patient In order to evaluate patient satisfaction with both DBS sampling devices patients will receive two kits for home use of both HemaXis DB 10 and Mitra Clamshell Patients will be asked to perform four blood trough concentrations at home two with every device After obtaining the fourth sample patients will be asked to send the samples by post to the laboratory In order to evaluate patient satisfaction with both DBS sampling devices patients will be asked to fill the System Usability Scale SUS
Main study parametersendpoints The primary endpoint is the method agreement between whole blood sample WBS and DBS The secondary endpoints are the success rate of DBS and the difference in SUS score between HemaXis DB 10 and Mitra Clamshell
Objective The primary objective is to perform a clinical validation of the analytical method for dried blood spot microsampling of cabozantinib pazopanib sunitinib Lenvatinib nivolumab ipilimumab pembrolizumab atezolizumab or bevacizumab The secondary objective is to test the feasibility of home monitoring microsampling TDM of cabozantinib pazopanib sunitinib Lenvatinib nivolumab ipilimumab pembrolizumab atezolizumab or bevacizumab in oncology patients
Study design A single center prospective clinical validation study Study population Patients treated in the LUMC with cabozantinib pazopanib sunitinib lenvatinib nivolumab ipilimumab pembrolizumab atezolizumab or bevacizumab
Intervention if applicable Patients who use an oral oncolytic will be asked to provide twelve microsamples obtained by finger prick eight dried blood spots DBS and four wet blood samples in microtainer EDTA and four paired whole blood WB samples obtained by venapuncture The paired samples have to be obtained within 5 minutes of each other Sampling will take place before the ingestion of the oral oncolytic through concentration Cthrough and every hour for three hours after drug administration C1 C2 and C3
Patients who receive immune checkpoints inhibitors will be asked to provide eight microsamples obtained by finger prick six DBS and two wet blood in microtainer EDTA and two paired WB samples obtained by venapuncture Sampling will take place just before infusion Ctrough and 15 minutes after the end of the infusion Cinfusion025 of the next cycle of immune checkpoint inhibitors Microsampling collection will be performed using two different sampling devices HemaXis DB 10 and Mitra Clamshell Patients will be assisted by a research nurse with the sampling of the first spot and the sampling of the remaining spots will be performed by the patient In order to evaluate patient satisfaction with both DBS sampling devices patients will receive two kits for home use of both HemaXis DB 10 and Mitra Clamshell Patients will be asked to perform four blood trough concentrations at home two with every device After obtaining the fourth sample patients will be asked to send the samples by post to the laboratory In order to evaluate patient satisfaction with both DBS sampling devices patients will be asked to fill the System Usability Scale SUS
Main study parametersendpoints The primary endpoint is the method agreement between whole blood sample WBS and DBS The secondary endpoints are the success rate of DBS and the difference in SUS score between HemaXis DB 10 and Mitra Clamshell
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None