Clinical trial NCT04484064: Optimization of the Targeted Anticancer Therapies
Official title: Optimization of Targeted Anticancer Therapies: a Systematic Collection and Modeling of Pharmacokinetic Data and Elaboration of an Adherence Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
Medication adherence
Oral targeted anticancer drugs
Population pharmacokinetics
Pharmacodynamic-pharmacokinetics relationships
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Krebsforschung Schweiz, Bern, Switzerland
First posted: 2020-07-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Cancer patients to whom a targeted anticancer therapy is prescribed

Exclusion Criteria:

* Patients incapable of judgment or participants under tutelage

Primary outcomes:
measure: Blood concentrations of targeted anticancer drugs
timeFrame: A maximum of 8 blood samples are collected within 2 years after the inclusion (at maximum 1 blood sample per month).
measure: Apparition of adverse events of targeted anticancer drugs
timeFrame: 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.
measure: Change from treatment start in efficacy of targeted anticancer drugs
timeFrame: 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 outcomes:
measure: Medication adherence : persistence rate and daily implementation of targeted anticancer drugs
timeFrame: 12 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
affiliation: Clinical Pharmacy Sciences
name: Chantal Csajka, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bandiera C, Cardoso E, Locatelli I, Digklia A, Zaman K, Diciolla A, Cristina V, Stravodimou A, Veronica AL, Dolcan A, Sarivalasis A, Liapi A, Bouchaab H, Orcurto A, Dotta-Celio J, Peters S, Decosterd L, Widmer N, Wagner D, Csajka C, Schneider MP. Optimizing Oral Targeted Anticancer Therapies Study for Patients With Solid Cancer: Protocol for a Randomized Controlled Medication Adherence Program Along With Systematic Collection and Modeling of Pharmacokinetic and Pharmacodynamic Data. JMIR Res Protoc. 2021 Jun 29;10(6):e30090. doi: 10.2196/30090.