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Recruiting NCT05789667

Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer

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Trial Parameters

Condition Differentiated Thyroid Cancer
Sponsor Regina Elena Cancer Institute
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-05-27
Completion 2024-12-01
Interventions
Lenvatinib

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Brief Summary

Lenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. Despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer. The primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. The secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to RECIST criteria 1.1; progression free survival, overall survival and duration of response.

Eligibility Criteria

Inclusion Criteria: * Patients with refractory iodine DTC treated with lenvatinib * Signed written informed consent Exclusion Criteria: \- Age \< 18 years

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