Optimization of the Targeted Anticancer Therapies

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Blood concentrations of targeted anticancer drugs [Срок оценки: A maximum of 8 blood samples are collected within 2 years after the inclusion (at maximum 1 blood sample per month).]
• Apparition of adverse events of targeted anticancer drugs [Срок оценки: 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.]
• Change from treatment start in efficacy of targeted anticancer drugs [Срок оценки: 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.]

Вторичные конечные точки (1)

• Medication adherence : persistence rate and daily implementation of targeted anticancer drugs [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Cancer patients to whom a targeted anticancer therapy is prescribed

Критерии исключения

• Patients incapable of judgment or participants under tutelage

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Швейцария · 1 центр

• CHUV — Lausanne

Публикации

• Bandiera C, Cardoso E, Locatelli I, Zaman K, Diciolla A, Digklia A, Stravodimou A, Cristina V, Aedo-Lopez V, Dolcan A, Sarivalasis A, Bouchaab H, Pasquier J, Dotta-Celio J, Peters S, Wagner D, Csajka C, Schneider MP. A pharmacist-led interprofessional medication adherence program improved adherence to oral anticancer therapies: The OpTAT randomized controlled trial. PLoS One. 2024 Jun 7;19(6):e030 PMID 38848380
• 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 Alo PMID 34185020

Идентификаторы

NCT: NCT04484064 · CHUV-PCL-OpTAT-2015 · 65/15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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