<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04484064</url>
  </required_header>
  <id_info>
    <org_study_id>CHUV-PCL-OpTAT-2015</org_study_id>
    <secondary_id>65/15</secondary_id>
    <nct_id>NCT04484064</nct_id>
  </id_info>
  <brief_title>Optimization of the Targeted Anticancer Therapies</brief_title>
  <acronym>OpTAT</acronym>
  <official_title>Optimization of Targeted Anticancer Therapies: a Systematic Collection and Modeling of Pharmacokinetic Data and Elaboration of an Adherence Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Krebsforschung Schweiz, Bern, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study includes an observational pharmacokinetic study and an interventional medication&#xD;
      adherence study. The purpose of this study is 1) to describe the concentration-time profiles&#xD;
      of targeted anticancer drugs and to characterize the concentration-effect/toxicity&#xD;
      relationships in the target population of patients (observational study) and 2) to&#xD;
      characterize patterns of adherence to oral targeted anticancer drugs and identify key-driver&#xD;
      modifiable adherence factors in patients participating in an adherence program&#xD;
      (interventional study).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Targeted anticancer therapies are often prescribed at the same dosage regimen in all&#xD;
      patients. However, it is known that the marked interindividual variability in drug level may&#xD;
      affect treatment outcomes. Several factors are known to modulate drug levels, such as weight,&#xD;
      genetics host-drug and drug-drug interaction. The identification of these factors could give&#xD;
      the possibility to propose better adjusted dosage regimens according to patient's individual&#xD;
      characteristics. Moreover, the presence of high or low drug concentrations may partially&#xD;
      explain toxicity or lack of efficacy of targeted anticancer drugs in some patients. The&#xD;
      characterization of the relationship between drug levels and treatment response (efficacy and&#xD;
      toxicity) would allow an optimized and a more individualized patient management with targeted&#xD;
      anticancer drugs.&#xD;
&#xD;
      Oral targeted therapies must be taken on the long term and adherence issues have been shown&#xD;
      to compromise treatment efficacy. Side effects and lifestyle management are among factors&#xD;
      affecting treatment adherence. The characterization of adherence over time and the&#xD;
      identification of factors susceptible to improve it will represent a great benefit for&#xD;
      healthcare professionals and patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood concentrations of targeted anticancer drugs</measure>
    <time_frame>A maximum of 8 blood samples are collected within 2 years after the inclusion (at maximum 1 blood sample per month).</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparition of adverse events of targeted anticancer drugs</measure>
    <time_frame>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.</time_frame>
    <description>Adverse events are assessed during the routine medical visits according the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE scale).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from treatment start in efficacy of targeted anticancer drugs</measure>
    <time_frame>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.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication adherence : persistence rate and daily implementation of targeted anticancer drugs</measure>
    <time_frame>12 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the &quot;standard care&quot; arm will use an electronic adherence monitor (MEMS®) without any feedback (electronic data will be blinded to patients, clinicians and investigators until the analysis)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adherence program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the &quot;adherence program&quot; will use the MEMS® and the pharmacist will provide an electronic feedback on medication adherence since the last visit. The identified determinants of medication adherence will be discussed with the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adherence program</intervention_name>
    <description>This program combines adherence evaluation using an electronic monitor (MEMS®) and feedback with repeated medication adherence interviews with the pharmacist.</description>
    <arm_group_label>Adherence program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cancer patients to whom a targeted anticancer therapy is prescribed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients incapable of judgment or participants under tutelage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chantal Csajka, PharmD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Pharmacy Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chantal Csajka, PharmD, PhD</last_name>
    <phone>21 314 42 63</phone>
    <phone_ext>+41</phone_ext>
    <email>chantal.csajka@chuv.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHUV</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chantal Csajka, PharmD PhD</last_name>
      <phone>21 314 42 63</phone>
      <phone_ext>+41</phone_ext>
      <email>chantal.csajka@chuv.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 28, 2016</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Chantal Csajka</investigator_full_name>
    <investigator_title>Director and Professor of the Center for Research and Innovation in Clinical Pharmaceutical Sciences</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Medication adherence</keyword>
  <keyword>Oral targeted anticancer drugs</keyword>
  <keyword>Population pharmacokinetics</keyword>
  <keyword>Pharmacodynamic-pharmacokinetics relationships</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484064
org study id: CHUV-PCL-OpTAT-2015
secondary id: 65/15
nct id: NCT04484064
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Blood concentrations of targeted anticancer drugs
time frame: A maximum of 8 blood samples are collected within 2 years after the inclusion (at maximum 1 blood sample per month).
description: 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.
measure: Apparition of adverse events of targeted anticancer drugs
time frame: 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.
description: Adverse events are assessed during the routine medical visits according the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE scale).
measure: Change from treatment start in efficacy of targeted anticancer drugs
time frame: 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.
description: 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.
measure: Medication adherence : persistence rate and daily implementation of targeted anticancer drugs
time frame: 12 months
description: 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).
arm group label: Standard care
arm group type: No Intervention
description: Patients in the "standard care" arm will use an electronic adherence monitor (MEMS®) without any feedback (electronic data will be blinded to patients, clinicians and investigators until the analysis)
arm group label: Adherence program
arm group type: Experimental
description: Patients in the "adherence program" will use the MEMS® and the pharmacist will provide an electronic feedback on medication adherence since the last visit. The identified determinants of medication adherence will be discussed with the patient.
intervention type: Behavioral
intervention name: Adherence program
description: This program combines adherence evaluation using an electronic monitor (MEMS®) and feedback with repeated medication adherence interviews with the pharmacist.
arm group label: Adherence program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chantal Csajka, PharmD, PhD
role: Principal Investigator
affiliation: Clinical Pharmacy Sciences
last name: Chantal Csajka, PharmD, PhD
phone: 21 314 42 63
phone ext: +41
email: chantal.csajka@chuv.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Chantal Csajka
investigator title: Director and Professor of the Center for Research and Innovation in Clinical Pharmaceutical Sciences
sharing ipd: Undecided