An Early Phase 1 interventional study of variability-based lenvatinib regimen in Lenvatinib Treatment, sponsored by Hadassah Medical Organization. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Hadassah Medical Organization · Early Phase 1, Interventional, and Treatment
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.
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.
Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
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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.
disease progression/ tumor response
tumor response according to positron emission tomography-computed tomography (PET-CT) and tumor markers (thyroglobulin)
Time frame: at enrollment and at study completion (14 weeks later)
Adverse effects occurrence
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.
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.
Plan to share: No — irrelevant
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Hadassah Medical Organization