Optimization of the Targeted Anticancer Therapies

Cancer Clinical Trial

— OpTAT  

Official title:

Optimization of Targeted Anticancer Therapies: a Systematic Collection and Modeling of Pharmacokinetic Data and Elaboration of an Adherence Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04484064
• Other study ID #: CHUV-PCL-OpTAT-2015
• Secondary ID: 65/15
• Status: Recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 2030

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Chantal Csajka, PharmD, PhD
• Phone: 21 314 42 63
• Email: chantal.csajka[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study includes an observational pharmacokinetic study and an interventional medication adherence study. The purpose of this study is 1) to describe the concentration-time profiles of targeted anticancer drugs and to characterize the concentration-effect/toxicity relationships in the target population of patients (observational study) and 2) to characterize patterns of adherence to oral targeted anticancer drugs and identify key-driver modifiable adherence factors in patients participating in an adherence program (interventional study).

Description:

Targeted anticancer therapies are often prescribed at the same dosage regimen in all patients. However, it is known that the marked interindividual variability in drug level may affect treatment outcomes. Several factors are known to modulate drug levels, such as weight, genetics host-drug and drug-drug interaction. The identification of these factors could give the possibility to propose better adjusted dosage regimens according to patient's individual characteristics. Moreover, the presence of high or low drug concentrations may partially explain toxicity or lack of efficacy of targeted anticancer drugs in some patients. The characterization of the relationship between drug levels and treatment response (efficacy and toxicity) would allow an optimized and a more individualized patient management with targeted anticancer drugs.

Oral targeted therapies must be taken on the long term and adherence issues have been shown to compromise treatment efficacy. Side effects and lifestyle management are among factors affecting treatment adherence. The characterization of adherence over time and the identification of factors susceptible to improve it will represent a great benefit for healthcare professionals and patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2030
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cancer patients to whom a targeted anticancer therapy is prescribed

Exclusion Criteria:

• Patients incapable of judgment or participants under tutelage

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Adherence program
This program combines adherence evaluation using an electronic monitor (MEMS®) and feedback with repeated medication adherence interviews with the pharmacist.

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	Vaud

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, Krebsforschung Schweiz, Bern, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood concentrations of targeted anticancer drugs	During their medical visits, from 1 to 8 blood samples will be collected per patients at the same moment as routine blood sampling. Drug concentration will be measured by HPLC-MS/MS.	A maximum of 8 blood samples are collected within 2 years after the inclusion (at maximum 1 blood sample per month).
Primary	Apparition of adverse events of targeted anticancer drugs	Adverse events are assessed during the routine medical visits according the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE scale).	Adverse events are monitored at each medical visit (once per month) from the inclusion in the study during 2 years maximum or from the inclusion in the study to the end of the treatment.
Primary	Change from treatment start in efficacy of targeted anticancer drugs	The progression free survival (PFS) is used to evaluate the drug efficacy. The PFS is defined as the time interval between the first dose of drug and the date of progression or any cause death. Patient without progression at the study end will be censored.	The cancer progression is evaluated at each PET-scan (once per 3 months) from the inclusion in the study during 2 years maximum or from the inclusion in the study to the end of the treatment.
Secondary	Medication adherence : persistence rate and daily implementation of targeted anticancer drugs	Adherence to oral anticancer therapies will be monitored thanks to Electronic monitoring Systems (MEMS, AARDEX) during maximum 12 months. This is a 1:1 randomized medication adherence intervention, which compares an intervention group vs. usual care. The intervention consists in monthly motivational interviewing sessions between the patient and the pharmacist, along with the delivering of oral targeted anticancer drugs in electronic pill bottles (Electronic Event Monitoring EEM, MEMSTM, AARDEX Ltd.). The patient meet the pharmacist after each clinical visits (usually once per month).	12 months