Clinical trial · Interventional
Using Chronobiology to Improve Lenvatinib Efficacy
A Controlled Trial for Improving the Response to Lenvatinib in Patients With Drug-resistant Thyroid Cancer by Chronobiology
NCT06321120CI-TRIAL-00075259unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lenvatinib Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| variability-based lenvatinib regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Variability-based lenvatinib treatment
- description
- 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.
- interventionNames
- Drug: variability-based lenvatinib regimen
Primary outcomes (1)
- measure
- disease progression/ tumor response
- timeFrame
- at enrollment and at study completion (14 weeks later)
- description
- tumor response according to positron emission tomography-computed tomography (PET-CT) and tumor markers (thyroglobulin)
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDSchlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. doi: 10.1056/NEJMoa1406470. PMID 25671254
- BACKGROUNDGelman R, Hurvitz N, Nesserat R, Kolben Y, Nachman D, Jamil K, Agus S, Asleh R, Amir O, Berg M, Ilan Y. A second-generation artificial intelligence-based therapeutic regimen improves diuretic resistance in heart failure: Results of a feasibility open-labeled clinical trial. Biomed Pharmacother. 2023 May;161:114334. doi: 10.1016/j.biopha.2023.114334. Epub 2023 Mar 9. PMID 36905809
- BACKGROUNDIlan Y. Overcoming Compensatory Mechanisms toward Chronic Drug Administration to Ensure Long-Term, Sustainable Beneficial Effects. Mol Ther Methods Clin Dev. 2020 Jun 10;18:335-344. doi: 10.1016/j.omtm.2020.06.006. eCollection 2020 Sep 11. PMID 32671136
- BACKGROUNDIlan Y, Spigelman Z. Establishing patient-tailored variability-based paradigms for anti-cancer therapy: Using the inherent trajectories which underlie cancer for overcoming drug resistance. Cancer Treat Res Commun. 2020;25:100240. doi: 10.1016/j.ctarc.2020.100240. Epub 2020 Nov 19. PMID 33246316