Using Chronobiology to Improve Lenvatinib Efficacy

March 17, 2024 updated by: Hadassah Medical Organization

A Controlled Trial for Improving the Response to Lenvatinib in Patients With Drug-resistant Thyroid Cancer by Chronobiology

The goal of this proof-of-concept clinical trial is to assess the efficacy and safety of chronobiology implementation into lenvatinib treatment regimens of thyroid cancer patients, via a mobile application.

Participants will use a mobile application to follow variability-based physician approved drug administration schedules.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Systemic treatments for thyroid cancer have emerged in the past decade, accompanied by a deeper understanding of its underlying molecular mechanisms. Among these, lenvatinib, a multi-targeted tyrosine kinase inhibitor, was approved as a monotherapy for treating locally advanced or metastatic radioactive iodine refractory differentiated thyroid cancer. Despite its efficacy, lenvatinib is associated with a spectrum of adverse events (AEs), including hypertension, fatigue, proteinuria, and gastrointestinal disturbances, which often necessitate dose reduction, interruption, or permanent discontinuation. To overcome these challenges, the investigators address to the Constrained Disorder Principle (CDP), an innovative approach that emphasizes the exploration of constrained variability in treatment regimens to optimize drug effectiveness and minimize AEs. In other disease contexts, such as congestive heart failure, multiple sclerosis, and chronic pain, the integration of CDP-based second-generation artificial intelligence (AI) systems into treatment regimens has shown promising results in enhancing therapeutic outcomes by dynamically adjusting treatment parameters. The investigators hypothesize that a personalized dynamic adjustment of lenvatinib dosages and administration timing, guided by an AI-driven approach via a mobile application, may reduce AEs, improve adherence, and enhance overall treatment efficacy. In this proof-of-concept study, the investigators aim to evaluate the feasibility and efficacy of utilizing a CDP-based second-generation AI system to optimize the therapeutic regimen of lenvatinib in patients with cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Organization
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-80 years
  2. Lenvatinib treated cancer patients, who suffer from loss of response of dose-limiting adverse effects.

Exclusion Criteria:

  1. Current or history of drug abuse
  2. Pregnancy/lactation/planned pregnancy
  3. The subject is currently enrolled in or has not yet completed at least 60 days since ending another investigational device or drug trial.
  4. Unable to comply with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Variability-based lenvatinib treatment
Dosages and administration times were tailored within individual predefined ranges to accommodate personalized therapeutic regimens. The first level of the algorithm, employed in the present study, utilizes a pseudo-random number generator to select dosages and administration times from the ranges stipulated by the physician.
Drug: variability-based lenvatinib regimen
Dosages and administration times were tailored within individual predefined ranges to accommodate personalized therapeutic regimens. As per protocol, the daily dose was limited to match or remain below the patients' pre-enrollment dosage level. In the initial 4 weeks of the follow-up, participants followed a fixed standard regimen with the app serving as a reminder, allowing for an adaptation period. Subsequently, the algorithm-driven treatment plan was implemented for an additional 10 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
disease progression/ tumor response
Time Frame: at enrollment and at study completion (14 weeks later)
tumor response according to positron emission tomography-computed tomography (PET-CT) and tumor markers (thyroglobulin)
at enrollment and at study completion (14 weeks later)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse effects occurrence
Time Frame: Blood tests will be drawn at enrollment and at study completion (14 weeks later). Telephone check-ups will be conducted monthly during the follow-up.
Safety assessments are performed throughout the study and include the recording of symptoms and emergency room visits or hospitalizations through a regular monthly telephone check-up and a hospital and ambulatory medical records review. Additionally, patients can report AEs online via the application. Hematological and biochemical laboratory testing, urinalysis, and self-conducted home blood pressure monitoring are also executed.
Blood tests will be drawn at enrollment and at study completion (14 weeks later). Telephone check-ups will be conducted monthly during the follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0749-21-HMO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

irrelevant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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