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CancerOpTATNCT04484064

Optimization of the Targeted Anticancer Therapies

A study testing Adherence program in people with Cancer, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Adherence program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteSwitzerland
Study dates
May 2015to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cancer patients to whom a targeted anticancer therapy is prescribed

Who cannot join

  • Patients incapable of judgment or participants under tutelage

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chantal Csajka, PharmD, PhD contact

21 314 42 63 ext. +41

chantal.csajka@chuv.ch

Switzerland1 site, 1 recruiting

  • CHUV

    Lausanne, Canton of Vaud, 1011

    Chantal Csajka, PharmD PhD, 21 314 42 63 ext. +41, chantal.csajka@chuv.ch

    Recruiting

Other trials in Switzerland

About this study

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

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).

Read the 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.

Conditions
Cancer
Being tested
Adherence program
Keywords
Cancer, Medication adherence, Oral targeted anticancer drugs, Population pharmacokinetics, Pharmacodynamic-pharmacokinetics relationships
Medical subject headings
Neoplasms, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adherence programBehavioural

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

Study groups in NCT04484064
Study groupRoleWhat they receive
Standard careNo interventionPatients 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)
Adherence programExperimentalPatients 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.
Receives: Behavioral: Adherence program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: A maximum of 8 blood samples are collected within 2 years after the inclusion (at maximum 1 blood sample per month).

  2. 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).

    Measured: 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.

  3. 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.

    Measured: 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 (1)

  1. 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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study startMay 2015
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04484064
Sponsor's protocol ID
CHUV-PCL-OpTAT-2015
Other IDs
65/15
Acronym
OpTAT
Status last verified
Jul 2020
First submitted
28 Jan 2016
Last updated
23 Jul 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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):e0304573. doi: 10.1371/journal.pone.0304573. eCollection 2024.

    PubMed 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 Along With Systematic Collection and Modeling of Pharmacokinetic and Pharmacodynamic Data. JMIR Res Protoc. 2021 Jun 29;10(6):e30090. doi: 10.2196/30090.

    PubMed 34185020

Questions about this trial

What is this clinical trial studying?

A study testing Adherence program in people with Cancer, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chantal Csajka, PharmD, PhD (21 314 42 63 ext. +41, chantal.csajka@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04484064, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.

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